FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT KNEE STRYKER
MDR report key: 2871896
·
Received December 6, 2012
Report
- Report Number
- 2249697-2012-02538
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- February 29, 2012
- Report Date
- November 15, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 BEEN EXPERIENCING PAIN IN HIS KNEE. PATIENT HAS PHYSICAL THERAPY WITH NO IMPROVEMENT. PATIENT ALSO STATES THAT HIS SURGEON MANUALLY MANIPULATED HIS KNEE 130 DEGREES UNDER ANESTHESIA. PATIENT IS REPORTING BEING IN CONSTANT PAIN. PATIENT IS LOOKING FOR A NEW SURGEON BECAUSE, HE HAS SO MUCH PAIN. PATIENT IS REPORTING THAT HE HAD THE KNEE REPAIRED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT KNEE STRYKER | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |