VERSA-DIAL/COMP TI STD TAPER
Report
- Report Number
- 0001825034-2019-05661
- Event Type
- Injury
- Date Received
- January 7, 2020
- Date of Event
- December 7, 2019
- Report Date
- May 22, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- UDI-DI
- 00880304217249
- PMA / PMN Number
- K060716
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION: IMPLANT DATE IS CORRECTED. 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. CORRECTION: G4 SHOULD HAVE BEEN DEC 6, 2019 AND NOT DEC 12, 2019. THE REPORTED EVENT WAS CONFIRMED BY A REVIEW OF X-RAYS. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SEPARATION OF THE GLENOSPHERE FROM THE BASE PLATE OF THE REVERSE-TYPE RIGHT SHOULDER ARTHROPLASTY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01839.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. THE COMPREHENSIVE STEM HAD FRACTURED. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#113634; COMP PRIMARY STEM 14MM MINI; LOT# 300540, ITEM# 110031424; CR VIVACIT-E 36MM BRNG STD; LOT# 64343846, ITEM# 110031402; MINI TRAY STD COCR +3 OFFSET; LOT# 64327562, ITEM# 115310; COMP RVRS SHLDR GLNSP STD 36MM; LOT# 664970, ITEM# 115395; COMP RVS CNTRL 6.5X25MM ST/RST; LOT# 139000, ITEM# 180558; COMP NLK SCR 3.5HEX 4.75X20 ST; LOT# 236640, ITEM# 180552; COMP LK SCR 3.5HEX 4.75X25 ST; LOT# 795520, ITEM# 180551; COMP LK SCR 3.5HEX 4.75X20 ST; LOT# 641130, ITEM# 115330; COMP RVRS SHDR GLEN BSPLT +HA; LOT# 760180. REPORT SOURCE: FOREIGN: EVENT HAPPENED IN (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05662. REMAINS IMPLANTED.
IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES. 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 |
|---|---|---|---|---|---|---|---|
| 19217 | VERSA-DIAL/COMP TI STD TAPER | PROSTHESIS, EXTREMITIES | KWS | ZIMMER BIOMET, INC. | N/A | 349060 | 00880304217249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |