ALLOFIT IT ALLOCLASSIC ACETABULAR SHELL 48/GG
Received Aug 25, 2022 · Event occurred Jul 26, 2022
Report 0009613350-2022-00433 · MDR key 15291333
Device
Generic name
Hip Prosthesis
Manufacturer
Zimmer Switzerland Manufacturing GmbhModel number
N/ACatalog number
00-8755-048-00
Lot number
3113952
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE IMPLANTATION OF A HIP PROSTHESIS THE INLAY COULD NOT BE ANCHORED INTO THE CUP. ANOTHER INLAY WAS USED. CUP REMAINED IMPLANTED. NO PATIENT HARM WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE: FOREIGN - GERMANY. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED DEVICE: IT XLPE LINERS, REFERENCE NUMBER: 00875200832, LOT NUMBER: 65310392. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.