UNK
Report
- Report Number
- 1220246-2024-07757
- Event Type
- Injury
- Date Received
- September 19, 2024
- Date of Event
- August 23, 2024
- Report Date
- June 10, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- PHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 501
Narratives
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 A PATIENT-SPECIFIC EVENT.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED ON 10/09/2024: THEY COULD NOT PROVIDE THE PART/LOT NUMBERS OF THE IMPLANTS IN THE PATIENT ON THE DAY OF THE ORIGINAL SURGERY. ALL COMPONENTS THAT WERE REMOVED FROM THE PATIENT IN THE REVISION WERE DISCARDED. THE ARTHREX PRODUCTS THAT WERE IMPLANTED AFTER THE EXTRACTION OF THE OLD COMPONENTS ARE PROVIDED BELOW: AR-9564-2436-LAT GLENOSPHERE / LOT: 23.03856, AR-9503S-03C HUMERAL INSERT / LOT:23.00580, AR-9555-15 SPACER / LOT: 23.00325, AR-9502F-36LCPC SUTURECUP / LOT: 23.02079.
ON 08/23/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9625 3.0 MM HEX DRIVER HAD THE TIP BROKEN OFF IN THE AR-9621-35T 35 MM TAP SCREW HEAD. ALL FRAGMENTS WERE FOUND, AND THE CASE WAS DELAYED APPROXIMATELY 10 MINUTES. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 09/11/2024: THIS WAS A REVISION DUE TO THE PATIENT HAVING AN INFECTION. THE PATIENT HAS HAD A LONG HISTORY OF SHOULDER SURGERIES AND INFECTIONS, AND, THEREFORE, THIS WAS A REMOVAL OF SOME ARTHREX ARTHROPLASTY IMPLANTS WHILE OTHER IMPLANTS WERE LEFT IN PLACE. THE TIP OF THE AR-9621-35T 35 MM TAP SCREW HEAD BROKE WHEN REMOVING THE OLD HUMERAL INSERT POLY, AND THE TIP OF THE AR-9625 3.0 MM HEX DRIVER BROKE OFF INTO THE HEAD OF THE GLENOSPHERE SCREW WHEN GOING TO REMOVE THE GLENOSPHERE IMPLANT. A SMALL FRAGMENT FROM THE AR-9621-35T 35 MM TAP TIP BROKE OFF WHEN THE SURGEON REMOVED THE OLD HUMERAL INSERT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE GLENOSPHERE, HUMERAL INSERT, SPACER, AND SUTURE CUP REMOVED AND REPLACED WITH NEW COMPONENTS. THE BASEPLATE, CENTRAL SCREW, LOCKING SCREWS, AND HUMERAL STEM WERE LEFT IN PLACE FROM THE PREVIOUS SURGERY. THIS OCCURRED ON (B)(6) 2024 FOR A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1488404 | UNK | SHOULDR PROSTH, REVERSE CONFIG | PHX | ARTHREX, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |