COMP AUG MINI BSPLT W TPR MD
Report
- Report Number
- 0001825034-2022-00448
- Event Type
- Injury
- Date Received
- March 2, 2022
- Date of Event
- February 17, 2022
- Report Date
- November 22, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- UDI-DI
- 00880304993242
- PMA / PMN Number
- K172502
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT PRODUCTS: COMP RVS TRAY CO 44MM CAT: 115370 LOT: UNKNOWN; ARCOM XL 44-36 STD HMRL BRNG 36MM CAT: XL-115363 LOT: 874890; COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 502220. REPORT SOURCE: FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00445, 0001825034-2022-00446, 0001825034-2022-00447. PRODUCT NOT RETURNED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NOT REPORTABLE.- THE RETURNED FRAGMENT DOES NOT MATCH ANY OF THE RETURNED IMPLANTS. THIS EVENT WILL BE REPORTED UNDER MEDWATCH: 0001825034-2022-01296. 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. 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. D10: COMP RVS TRAY CO 44MM CAT: 115370 LOT: UNKNOWN ARCOM XL 44-36 STD HMRL BRNG 36MM CAT: XL-115363 LOT: 874890 COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 502220 FOREIGN: UNITED KINGDOM. THIS PRODUCT WAS DETERMINED TO BE POSSIBLY INVOLVED AS THE FOREIGN BODY WAS DETERMINED TO BE A TITANIUM ALLOY. 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. H3 OTHER TEXT : PRODUCT NOT RETURNED
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
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
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND THE HUMERAL TRAY, HUMERAL BEARING , GLENOSPHERE AND MINI TAPER ADAPTER WERE ALL EXCHANGED FOR NEW IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2293528 | COMP AUG MINI BSPLT W TPR MD | SHOULDER, PROSTHESIS | KWS | ZIMMER BIOMET, INC. | 110032420 | 64298726 | 00880304993242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Hospitalization| R | SEE H10| SEE H10 |