FDA Adverse Event
Injury
Summary report: N
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
MDR report key: 23618294
·
Received November 21, 2025
Report
- Report Number
- MW5179243
- Event Type
- Injury
- Date Received
- November 21, 2025
- Report Date
- November 19, 2025
- Manufacturer
- ZIMMER BIOMET CANADA DFE
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ATTUNE CR RP 3 MONTH. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2490710 | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/ | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/ | JWH | ZIMMER BIOMET CANADA DFE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |