COMP RVS CNTRL 6.5X25MM ST/RST
Report
- Report Number
- 0001825034-2020-02932
- Event Type
- Injury
- Date Received
- July 23, 2020
- Date of Event
- April 18, 2022
- Report Date
- July 12, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- PMA / PMN Number
- K132239
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(6). REPORTED EVENT WAS CONFIRMED VIA X-RAYS WHICH STATED THAT THE THREE VIEWS OF THE LEFT SHOULDER DEMONSTRATE A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH POSSIBLE LOOSENING OF THE GLENOID BASEPLATE COMPONENT OF THE GLENOSPHERE. ALSO, RADIOLUCENCY IS SEEN ALONG THE CENTRAL SCREW AS WELL AS THE INFERIOR BASEPLATE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD STILL NOT BE DETERMINED. 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). UPDATED: A2, A3, A4, B4, B5, D1, D2, D4, D6, G4, G5, H1, H2, H3, H10. D11 - MEDICAL PRODUCT: CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 252390 CATALOG #: 180550, COMP LK SCR 3.5HEX, LOT # 712930 CATALOG #: 180550, COMP LK SCR 3.5HEX, LOT # 884770 CATALOG #: 180551, COMP LK SCR 3.5HEX, LOT # 641160 CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 668920 CATALOG #: 113612, COMP PRIMARY STEM 12MM MICRO, LOT # 191316 CATALOG #: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, LOT # 712130 CATALOG #: 110031424, CR VIVACIT-E 36MM BRNG STD, LOT # 64336638 CATALOG #: 110031399, MINI TRAY STD COCR +0 OFFSET, LOT # 64282531 H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL HAS DECLINED TO RETURN THE PRODUCT. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO (RELATED) DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. 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. COMPLAINT WAS MISTAKENLY REOPENED AS IT WAS IDENTIFIED THERE WAS A REVISION OF THE VRS IMPLANTED DURING THE REVISION OF THIS CASE. A NEW COMPLAINT WILL BE INITIATED AND THE PREVIOUS INVESTIGATION REMAINS UNCHANGED. 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. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2.5 YEARS POSTIMPLANTATION DUE TO BASEPLATE LOOSENING AND PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
(B)(4). (UDI): N/A. CONCOMITANT MEDICAL PRODUCT: CATALOG #: UNKNOWN, STEM, LOT #: UNKNOWN. CATALOG #: UNKNOWN, BASEPLATE, LOT #: UNKNOWN. CATALOG #: UNKNOWN, PERIPHERAL SCREW, LOT #: UNKNOWN. CATALOG #: UNKNOWN, PERIPHERAL SCREW, LOT #: UNKNOWN. CATALOG #: UNKNOWN, PERIPHERAL SCREW, LOT #: UNKNOWN. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02929, 0001825034-2020-02931, 0001825034-2020-02933, 0001825034-2020-02934, AND 0001825034-2020-02935.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT PLANS TO BE REVISED DUE TO LOOSENING AND PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776424 | COMP RVS CNTRL 6.5X25MM ST/RST | FIXATION. SCREW | KWS | ZIMMER BIOMET, INC. | N/A | 860660 | |
| 776437 | COMP RVS CNTRL 6.5X25MM ST/RST | FIXATION. SCREW | KWS | ZIMMER BIOMET, INC. | N/A | 860660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| H |