RINGLOC ACETABULAR LINER
Received Jul 20, 2017 · Event occurred Jun 6, 2017
Report 0001825034-2017-05083 · MDR key 6728754
Device
Generic name
Prosthesis Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
EP-108322
Lot number
495850
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
70 YR
- Joint Dislocation
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STEM, UNKNOWN CUP; 32 MM COCR MOD HD +6 MM NO SKIRT CATALOG 163674 LOT 654500. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, AS FOLLOW UP MDR WILL BE SUBMITTED MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001825034 - 2017 - 05085.
Description of Event or Problem
PATIENT UNDERWENT A THIRD CLOSED REDUCTION DUE TO DISLOCATION WITHIN ONE YEAR POST-IMPLANTATION.