G7 HI-WALL E1 LINER 36MM E
Report
- Report Number
- 0001825034-2022-00865
- Event Type
- Injury
- Date Received
- April 11, 2022
- Date of Event
- April 10, 2021
- Report Date
- September 6, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- UDI-DI
- 00880304527102
- PMA / PMN Number
- K121874
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
(B)(4). AGE OR DOB: 1966. CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN, HEAD LOT #: UNKNOWN, ITEM #: UNKNOWN, STEM LOT #: UNKNOWN, ITEM #: UNKNOWN, CUP LOT #: UNKNOWN. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CATALOG NUMBER:650-0836 LOT NUMBER:3033134 BRAND NAME: DELTA CERAMIC HEAD, CATALOG NUMBER:110010244 LOT NUMBER:6882116 BRAND NAME: G7 SHELL, CATALOG NUMBER:51-137090 LOT NUMBER:3975819 BRAND NAME: TPRLC 133 MP 12. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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.
IT WAS REPORTED BY THE PATIENTS LEGAL COUNSEL THAT THE PATIENT UNDERWENT AN INITIAL LEFT REPLACEMENT SURGERY. OVER A YEAR LATER, THE PATIENT UNDERWENT A REVISION SURGERY OF THE HEAD AND LINER. THE HEAD ALLEGEDLY SHOWED SIGNS OF WEAR FROM CONTACT WITH THE METAL SHELL AND MODEST METALLIC SOFT TISSUE. THE LINER WAS FOUND SHOWING COMPLETE RUPTURE OF THE LOCKING MECHANISM WITH NO OTHER SIGNS OF FAILURE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1822364 | G7 HI-WALL E1 LINER 36MM E | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | N/A | 6848102 | 00880304527102 |
| 2439181 | G7 HI-WALL E1 LINER 36MM E | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | N/A | 6848102 | 00880304527102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| R |