FDA Adverse Event
Injury
Summary report: N
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
MDR report key: 16774001
·
Received April 19, 2023
Report
- Report Number
- 3000931034-2023-00089
- Event Type
- Injury
- Date Received
- April 19, 2023
- Date of Event
- December 19, 2011
- Report Date
- April 19, 2023
- Manufacturer
- TORNIER S.A.S.
- Product Code
- KWS
- PMA / PMN Number
- K132285
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED UNDER CATALOG NUMBER DWE850 510K# K132285. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT (B)(4) UNDERWENT A REVISION SURGERY OF THE COMPLETE HUMERAL AND GLENOID SIDES DUE TO INSTABILITY/DISLOCATION. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1625360 | AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER S.A.S. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention |