FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER LEFT KNEE
MDR report key: 2860096
·
Received December 4, 2012
Report
- Report Number
- 2249697-2012-02517
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- October 19, 2001
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS BILATERAL KNEE IMPLANTS. THE PATIENT COMPLAINS OF PAIN, SWELLING, WEAKNESS AND INSTABILITY IN THE LEFT KNEE. THE PATIENT CANNOT STAND EVEN WITH ASSISTANCE AND MUST USE A WHEELCHAIR. THE PATIENT REPORTS THAT YOU CAN HEAR THE IMPLANTED PARTS MOVING IN THE KNEE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 FOR FIVE DAYS DUE TO INTENSE PAIN AND EXTREME SWELLING IN THE KNEE. SCANS REVEALED THAT THE LEFT IMPLANT IS UNSTABLE AND A REVISION SURGERY IS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER LEFT KNEE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |