E-POLY 40MM +3 MAXROM LINER SZ25
Received Feb 12, 2016 · Event occurred Jan 23, 2014
Report 0001825034-2016-00489 · MDR key 5434499
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
EP-108425
Lot number
320690
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
31 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00486 / 00491).
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO UNKNOWN REASONS. THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND AN ACTIVE ARTICULATION BEARING WAS IMPLANTED. A REVIEW OF INVOICE HISTORY REVEALED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. FURTHER REVIEW OF INVOICE HISTORY REVEALED LEFT HIP REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2014 UTILIZING CEMENT SPACER MOLDS AND ON (B)(6) 2014, DURING WHICH REIMPLANTATION OF TOTAL HIP COMPONENTS OCCURRED.