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Background <p>Orthopedic implant-associated adverse events (OIAEs) pose a significant challenge to patient safety. Infections, implant failures, allergic reactions, and the need for revision surgeries are among the most frequently reported complications. This study aimed to evaluate the nature and pattern of medical device adverse events (MDAEs) related to orthopedic implants at a Regional Training Center under the Materiovigilance Program of India.</p> Methods <p>A retrospective, observational study was conducted using spontaneously reported MDAEs at the Medical Device Monitoring Center (MDMC), at a tertiary care center in Central India, between July 2019 and September 2022. Reports were submitted by healthcare professionals, patients, or their caregivers. Data were collected using the Indian Pharmacopeia Commission (IPC) recommended MDAE reporting form and analyzed using Microsoft Excel and SPSS v1.0.0.1406. Causality was assessed using WHO-UMC criteria. Descriptive statistics (frequency, percentages) were used for analysis.</p> Results <p>A total of 92 MDAEs were reported, of which 88% were serious. Infections were the leading cause (73%), followed by dislocation (11%), allergic reactions (7%), implant loosening (5%), and metallosis or bent nails (2% each). Revision surgery was required in 76% of cases. The most frequently implicated devices included interlocking nails and tibia locking plates. Causality assessment categorized 58% as probable, 25% as possible, and the remainder as unlikely, unassessable, or not related.</p> Conclusion <p>This study highlights infections as the predominant OIAE, requiring revision surgeries in most cases. A robust materiovigilance system and increased awareness among healthcare providers are essential for timely detection and reporting of OIAEs to improve patient safety.</p>

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An Experience of Orthopedic Implant-Related Adverse Events at a Regional Training Center in Central India

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Ahmad Najmi,
  • Shilpa N. Kaore,
  • Rehan-Ul-Haq,
  • Manish Dwivedi,
  • S. Balakrishnan,
  • Mohammad Faizan Khan,
  • Chirag Agrawal

摘要

Background

Orthopedic implant-associated adverse events (OIAEs) pose a significant challenge to patient safety. Infections, implant failures, allergic reactions, and the need for revision surgeries are among the most frequently reported complications. This study aimed to evaluate the nature and pattern of medical device adverse events (MDAEs) related to orthopedic implants at a Regional Training Center under the Materiovigilance Program of India.

Methods

A retrospective, observational study was conducted using spontaneously reported MDAEs at the Medical Device Monitoring Center (MDMC), at a tertiary care center in Central India, between July 2019 and September 2022. Reports were submitted by healthcare professionals, patients, or their caregivers. Data were collected using the Indian Pharmacopeia Commission (IPC) recommended MDAE reporting form and analyzed using Microsoft Excel and SPSS v1.0.0.1406. Causality was assessed using WHO-UMC criteria. Descriptive statistics (frequency, percentages) were used for analysis.

Results

A total of 92 MDAEs were reported, of which 88% were serious. Infections were the leading cause (73%), followed by dislocation (11%), allergic reactions (7%), implant loosening (5%), and metallosis or bent nails (2% each). Revision surgery was required in 76% of cases. The most frequently implicated devices included interlocking nails and tibia locking plates. Causality assessment categorized 58% as probable, 25% as possible, and the remainder as unlikely, unassessable, or not related.

Conclusion

This study highlights infections as the predominant OIAE, requiring revision surgeries in most cases. A robust materiovigilance system and increased awareness among healthcare providers are essential for timely detection and reporting of OIAEs to improve patient safety.