FDA Adverse Event
Injury
Summary report: N
SPECIFIC DEVICE NOT REPORTED
MDR report key: 20301613
·
Received September 25, 2024
Report
- Report Number
- 1038671-2024-03699
- Event Type
- Injury
- Date Received
- September 25, 2024
- Date of Event
- May 16, 2014
- Report Date
- September 25, 2024
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
1038671-2024-01137.
Description of Event or Problem · 0
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2199182 | SPECIFIC DEVICE NOT REPORTED | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |