E-POLY 32MM +3 HIWALL LNR SZ22
Received Oct 4, 2018 · Event occurred Jun 6, 2017
Report 0001825034-2018-09264 · MDR key 7935765
Device
Generic name
Hip Prostheis
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108322
Lot number
131840
Product problems
- Fracture
- Insufficient Device Problem Information
- Fracture
- Insufficient Device Problem Information
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO CUP LOOSENING, WEAR, AND LINER FRACTURE. OPERATIVE NOTES INDICATED A LOOSE, MALPOSITIONED CUP, SURFACE SCRATCHING ON FEMORAL HEAD AND STEM, AND LINER WAS FRACTURED ALONG THE POSTERIOR LIP OF THE LINER.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # 11-104109, STEM, LOT # 692290; ITEM # 650-1056, FEMORAL HEAD, LOT # 495330; ITEM # 650-1064, TAPER SLEEVE, LOT # 341410; ITEM # PT-116048, CUP, LOT # 355760; ITEM # 31-323230, DRILL BIT, LOT # 797410; ITEM # 103533, BONE SCREW, LOT # 751420. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09263, 0001825034-2018-09264, 0001825034-2018-09265, 0001825034-2018-09266, 0001825034-2018-09437.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF PROVIDED PATIENT MEDICAL RECORDS THE REPORTED DEVICE LOOSENING AND FRACTURE EVENT. IN RELATION TO THIS DEVICE, THE LINER WAS IDENTIFIED AS FRACTURED. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ROOT CAUSE IS UNKNOWN. 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
NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.