FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER LEFT KNEE
MDR report key: 2870033
·
Received December 4, 2012
Report
- Report Number
- 2249697-2012-02555
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- June 1, 2012
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 IS REPORTED THAT APPROXIMATELY (B)(6) 2012, THE PATIENT BEGAN EXPERIENCING PAIN AND INSTABILITY IN THE LEFT KNEE. AFTER AN EXAMINATION, THE ORTHOPEDIST DETERMINED THAT THE LEFT KNEE IS SLIPPING OUT OF PLACE. IT IS REPORTED THAT THE PATIENT IS IN A GREAT DEAL OF PAIN AND THE INSTABILITY HAS LED TO A HIGH ANKLE SPRAIN. THE PATIENT CURRENTLY HAS DIFFICULTY WALKING AND USES A WALKER. THE PATIENT COMPLAINS OF A TENDER KNOT BEHIND THE LEFT KNEE, SWELLING AROUND THE JOINT, NUMBNESS, TINGLING AND BURNING. THE PATIENT HAS BILATERAL KNEE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER LEFT KNEE | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |