E1 RINGLOC ACETABULAR LINER
Received Oct 12, 2017 · Event occurred Sep 23, 2014
Report 0001825034-2017-08519 · MDR key 6945493
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108425
Lot number
558190
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
38 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03584, 0001825034-2017-08492. MEDICAL DEVICES: CER BIOLOXD OPTION HD 40MM CATALOG#: 650-1058 LOT#: 904340; REGEN/RNGLC+ MULTI 60MM SZ 25 CATALOG#: PT-106060 LOT#: 878770; CER OPT TYPE 1 TPR SLEVE 0MM CATALOG#: 650-1066 LOT#: 083520; ARCOS CON SZ D STD 70MM CATALOG#: 11-301324 LOT#: 906510; 5.0MMX40MM TI KAESSMANN SCREW CATALOG#: CP250313 LOT#: 146600; 5.0MMX45MM TI KAESSMANN SCREW CATALOG#: CP250314 LOT#: 778060; ARCOS 18X250MM INTLKNG DIST CATALOG#: 11-301918 LOT#: 128600. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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
PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO UNKNOWN REASONS. THE MODULAR HEAD AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED.