E-POLY 36MM +3 HIWALL LNR SZ23
Received Aug 19, 2019
Report 0001825034-2019-03669 · MDR key 8906902
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108323
Lot number
306240
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). EVENT DATE UNKNOWN. IMPLANTED IN (B)(6) 2014. CONCOMITANT MEDICAL PRODUCTS: 650-1057 ¿ BIOLOX DELTA HEAD ¿ 174850, 650-1064 ¿ CERAMIC TAPER SLEEVE ¿ 195410, 13-104150 ¿ MALLORY HEAD SHELL ¿ 750520, UNKNOWN STEM ¿ UNKNOWN PART AND LOT, THERAPY DATE: UNKNOWN. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO THE LINER COMPONENT BREAKING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.