EXCEED ABT E1 FLNG CUP 28X48MM
Received Mar 12, 2019 · Event occurred Feb 9, 2017
Report 3002806535-2019-00262 · MDR key 8412002
Device
Generic name
Hip Prosthesis
Manufacturer
Biomet Uk Ltd.Model number
N/ACatalog number
EP-102848
Lot number
3837700
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
61 YR
- Joint Dislocation
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
(B)(4). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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
HIP REVISION DUE TO DISLOCATION AND SUBLUXATION.