FDA Adverse Event
Injury
Summary report: N
MRH KNEE FEM S RGT
MDR report key: 22680678
·
Received July 31, 2025
Report
- Report Number
- 0002249697-2025-00773
- Event Type
- Injury
- Date Received
- July 31, 2025
- Date of Event
- December 7, 2013
- Report Date
- July 31, 2025
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KRO
- UDI-DI
- 07613327045147
- PMA / PMN Number
- K002552
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: PATELLAR TENDON RUPTURE. NO COMPONENTS REMOVED. RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179183 | MRH KNEE FEM S RGT | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | KRO | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN | 07613327045147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |