FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT HOWMEDICA TOTAL LEFT KNEE
MDR report key: 2062742
·
Received April 13, 2011
Report
- Report Number
- 2249697-2011-00453
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- January 25, 2005
- Report Date
- March 17, 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
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HER TOTAL KNEE REPLACEMENT BACK IN (B)(6) 2005. TWENTY ONE DAYS LATER (ON (B)(6) 2005) SHE HAD A REVISION BECAUSE OF A STAPH INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT HOWMEDICA TOTAL LEFT KNEE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |