UNK STEM
Received Jul 7, 2026 · Event occurred Mar 27, 2026
Report 0001822565-2026-02466 · MDR key 25736544
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Additional Manufacturer Narrative
(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. G2: FOREIGN: AUSTRALIA. THIS IS AN INITIAL/FINAL REPORT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.