inforMED
InjuryKRR

FEMORAL COMPONENT

Received Feb 20, 2024 · Event occurred Oct 19, 2023

Report 0001822565-2024-00596 · MDR key 18737720

Device

Generic name

Prosthesis Knee

Model number

N/A

Catalog number

00575201701

Lot number

64226041

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Prefer Not To Disclose

  • Pain
  • Pain

Narrative

Additional Manufacturer Narrative

(B)(4). D10 - MEDICAL PRODUCT: ARTICULAR SURFACE CATALOG # 00595204012 LOT # 64590070. ALL POLY PETELLA CATALOG # 00597206535 LOT # 64620687. STEMMED TIBIAL COMPONENT CATALOG # 00598004702 LOT # J6960308. STEM EXTENSION CATALOG # 00598801215 LOT # 64894141. HEADED SCREW 48 MM LENGTH CATALOG # 00579104100 LOT # 65003879. HEADED SCREW 48 MM LENGTH CATALOG # 00579104100 LOT # 65011599. HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 65011608. HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 65082493. HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 65082498. HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 65143820. HEADED SCREW 27 MM LENGTH CATALOG # 00579104300 LOT # 64744149. HEADED SCREW 27 MM LENGTH CATALOG # 00579104300 LOT # 64744149. G2: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2024-00597. 0002648920-2024-00044. 0001822565-2024-00598. 0002648920-2024-00045. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - FEMUR. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.