MODULAR HEAD COMPONENT
Received Oct 20, 2025
Report 0001825034-2025-03271 · MDR key 23336781
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
(B)(4). H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ABNORMAL ACETABULAR CUP POLYETHYLENE WEAR SUPERIORLY. STEEP ACETABULAR CUP LATERAL ANGLE OF INCLINATION AND VARUS POSITIONING OF THE FEMORAL STEM ARE BOTH MALIGNMENT'S THAT CAN CAUSE INCREASE CONTACT STRESS AND WEAR OF THE POLYETHYLENE AT THE SUPERIOR ACETABULAR CUP. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED. 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 APPROXIMATELY 22 YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A HIP REVISION DUE TO UNKNOWN REASONS, POSSIBLY POLY WEAR. THE REP WAS REQUESTING IMPLANT IDENTIFICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.