FDA Adverse Event
Injury
Summary report: N
DEPUY MITEK
MDR report key: 2465582
·
Received February 17, 2012
Report
- Report Number
- MW5024291
- Event Type
- Injury
- Date Received
- February 17, 2012
- Date of Event
- July 16, 2011
- Report Date
- February 12, 2012
- Manufacturer
- DEPUY MITEK, INC.
- Product Code
- MAI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AREA OF GROOVING ON FEMORAL CONDYLE AND A CORRESPONDING AREA ON THE TIBIAL SIDE. INFLAMMATION AND SYNOVIUM PROLONGED PAIN AND DYSFUNCTION IN KNEE JOINT. REASON FOR USE: MENISCAL REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY MITEK | RAPID LOC MENISCAL REPAIR-PLA TOPHAT/27 DEGREES | MAI | DEPUY MITEK, INC. | 0702211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention| S |