COMP RVS CNTRL 6.5X30MM ST/RST
Report
- Report Number
- 0001825034-2023-03055
- Event Type
- Injury
- Date Received
- December 22, 2023
- Report Date
- June 6, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- UDI-DI
- 00880304677081
- PMA / PMN Number
- K132239
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D2, D4, G1-2, G3, G4, G7, H1, H2, H4, H6, H10. D10: COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 65700031. COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 161090. COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 905700. COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 760800. COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 429670. 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 UPDATED: B4, B5, D2, G1-2, G3, G7, H1, H2, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR AS THE PATIENT WAS LIFTING A HOT WATER HEATER POST-OP. PER IFU, "EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, EXCESSIVE WEIGHT, AND OBESITY HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF CERTAIN IMPLANTS BY LOOSENING, FRACTURE, DISLOCATION, SUBLUXATION AND/OR WEAR." THE REPORTED EVENT IS CONFIRMED AS THE PATIENT WAS LIFTING A HOT WATER HEATER POST-OP CAUSING THE SCREW TO FRACTURE. 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.
(B)(4). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO SCREW FRACTURE. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195471 | COMP RVS CNTRL 6.5X30MM ST/RST | SHOULDER, PROSTHESIS | KWS | ZIMMER BIOMET, INC. | 036680 | 00880304677081 | |
| 2168857 | COMP RVS CNTRL 6.5X30MM ST/RST | SHOULDER, PROSTHESIS | KWS | ZIMMER BIOMET, INC. | 036680 | 00880304677081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Other| H| R |