RINGLOC HIP SYSTEM ACETABULAR LINER
Received Jun 12, 2018 · Event occurred May 11, 2018
Report 0001825034-2018-03890 · MDR key 7590481
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porou
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108223
Lot number
761320
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
47 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03891; 0001825034 - 2018 - 03894; 0001825034 - 2018 - 03896.
Description of Event or Problem
IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.