FDA Adverse Event
Injury
Summary report: N
SHOULDER COMPONENTS
MDR report key: 17032985
·
Received May 31, 2023
Report
- Report Number
- 1038671-2023-01183
- Event Type
- Injury
- Date Received
- May 31, 2023
- Date of Event
- June 11, 2021
- Report Date
- December 23, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWT
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PENDING EVALUATION.
Description of Event or Problem · 0
AS REPORTED, THIS 70 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED. THE PATIENT ORIGINALLY HAD AN EXACTECH REVERSE SHOULDER IMPLANTED. AT SOME POINT, THE GLENOSPHERE BECAME DISASSOCIATED FROM THE BASEPLATE. A SURGEON IN ROCKFORD IL REVISED THE SHOULDER IMPLANTS ON (B)(6) 2021 AT OSF SAINT ANTHONY. THE BASEPLATE AND STEM WERE NOT REMOVED BUT SCREWS WERE ADDED AND A NEW GLENOSPHERE AND LINER WERE IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1160767 | SHOULDER COMPONENTS | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | KWT | EXACTECH, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Hospitalization| R |