EXCEED ABT E1 FLNG CUP 28X46MM
Received Apr 17, 2019 · Event occurred Dec 22, 2017
Report 3002806535-2019-00371 · MDR key 8522085
Device
Generic name
Hip Prosthesis
Manufacturer
Biomet Uk Ltd.Model number
N/ACatalog number
EP-102846
Lot number
3837697
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
88 YR
- Joint Dislocation
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: 28MM MOD HD STD NECK TP1 TAPER, CATALOG #: 163662, LOT #: 00J3536062, MEDICAL PRODUCT: ARCOS CON SZ A STD 80MM HA, CATALOG #:22-301341, LOT #: 488280. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00372. 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.
Description of Event or Problem
HIP REVISION DUE TO DISLOCATION AND SUBLUXATION.