FDA Adverse Event
Other
Summary report: N
MJS ANATOMICAL KNEE
MDR report key: 1658024
·
Received April 13, 2010
Report
- Report Number
- 1644408-2010-00169
- Event Type
- Other
- Date Received
- April 13, 2010
- Date of Event
- March 15, 2010
- Report Date
- March 15, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K922859
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SINCE THE LOT NUMBER AND DATE OF IMPLANT ARE UNKNOWN, IT IS UNKNOWN IF THIS WAS AN ENCORE MEDICAL OR OSTEO TECHNOLOGY MANUFACTURED DEVICE.
Description of Event or Problem · 1
REVISION SURGERY WAS REQUIRED DUE TO POLY WEAR ON TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MJS ANATOMICAL KNEE | INSERT | JWH | ENCORE MEDICAL, L.P. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |