E-POLY 36MM +3 HIWALL LNR SZ23
Received Aug 3, 2016 · Event occurred Jun 7, 2016
Report 0001825034-2016-02851 · MDR key 5844022
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
EP-108323
Lot number
311450
Product problems
- Fracture
- Insufficient Device Problem Information
- Fracture
- Insufficient Device Problem Information
Patient
65 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - NI. MANUFACTURE DATE ¿ NI.
Description of Event or Problem
PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO AN UNKNOWN POLYETHYLENE FAILURE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
Description of Event or Problem
PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO FRACTURE OF THE POLYETHYLENE LINER.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.