UNIVERS VAULTLOCK GLENOID, LARGE
Report
- Report Number
- 1220246-2024-08656
- Event Type
- Malfunction
- Date Received
- November 27, 2024
- Date of Event
- November 4, 2024
- Report Date
- July 8, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- KWS
- UDI-DI
- 00888867239333
- PMA / PMN Number
- K161108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFORMATION: B5, G3, H6.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION
ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.
ADDITIONAL INFORMATION WAS RECEIVED ON 12/19/2024: ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A CASE DELAY OF THIRTY MINUTES WHILE WAITING FOR A SECOND IMPLANT. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE CASE WAS COMPLETED WITH A NEW IMPLANT WITH NO COMPLICATIONS. NO ADVERSE EFFECTS ON THE PATIENT REPORTED. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2024.
ON 11/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9106-03 UNIVERS VAULTLOCK GLENOID, LARGE HAD THE PEG DAMAGED DURING IMPLANTATION. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2368311 | UNIVERS VAULTLOCK GLENOID, LARGE | PROSTHESIS, SHOULDER, CEMENTED | KWS | ARTHREX, INC. | UNIVERS VAULTLOCK GLENOID, LARGE | 1027262120 | 00888867239333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |