FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT- STRYKER LEFT KNEE
MDR report key: 2070951
·
Received April 19, 2011
Report
- Report Number
- 2249697-2011-00505
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- February 14, 2005
- Report Date
- March 24, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO HE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT HAD SURGERY IN (B)(6) 2005. THE PAIN NEVER STOPPED. CAN NO LONGER GET AROUND OR WORK. FOUND FLUID ON HIS KNEE, WHICH WAS DRAWN OUT OF HIS KNEE. DR KEEPS SAYING THAT THE PAIN IS DUE TO HIS BACK, DOES NOT FIND ANYTHING WRONG WITH THE KNEE ITSELF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT- STRYKER LEFT KNEE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |