FDA Adverse Event
Injury
Summary report: N
UNI-KNEE TIBIAL INSERT 13 MM SIZE 3/4
MDR report key: 49958
·
Received November 20, 1996
Report
- Report Number
- 2935620-1996-00012
- Event Type
- Injury
- Date Received
- November 20, 1996
- Date of Event
- October 7, 1996
- Report Date
- November 19, 1996
- Manufacturer
- INTERMEDIC ORTHOPEDICS, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NOTICED OF REVISION SURGERY TO MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNI-KNEE TIBIAL INSERT 13 MM SIZE 3/4 Implant | KNEE IMPLANT PROSTHESIS | HSH | INTERMEDIC ORTHOPEDICS, INC. | NA | 19594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | 6100-00-050| 6100-00-140 |