UNK
Report
- Report Number
- 1220246-2025-04171
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- August 15, 2025
- Report Date
- November 12, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- MDM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- 501
Narratives
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 ¿ INCLUDING THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED EVENT. THE MOST LIKELY CAUSE IS A PATIENT-SPECIFIC EVENT, CONSISTENT WITH DFU GUIDANCE, WHICH STATES THAT ALLERGIC RESPONSES TO IMPLANT MATERIALS MAY OCCUR IN RARE CASES.
IT WAS REPORTED THAT DURING A REVISION SURGERY OF A SHOULDER PROSTHESIS, IT WAS NOT POSSIBLE TO USE THE AR-9401-17 IN THE NOTCHES AS USUAL. INSTEAD, THE IMPLANT HAD TO BE BROKEN UP AND THE EXTRACTION INSTRUMENT BROKE. IN ADDITION, AR-9545-T15-02 WAS WORN OUT ON ARRIVAL. THE DEVICE COULD BE USED DURING SURGERY BUT SHOULD NOT BE USED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH 12-SEP-25 MORE INFORMATION WAS PROVIDED THAT THE REVISION SURGERY WAS ACTUALLY THE REVISION OF AN UNKNOWN ARTHREX IMPLANT DUE TO AN INFECTION. THIS LINE IS ADDED FOR THE UNKNOWN IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303227 | UNK | MANUAL INSTR, GENERAL SURGICAL | MDM | ARTHREX, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |