FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT KNEE
MDR report key: 2232486
·
Received August 25, 2011
Report
- Report Number
- 2249697-2011-01251
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- April 4, 2011
- Report Date
- August 3, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE SUBJECT IS ENROLLED IN THE TRIATHLON TS STUDY. SUBJECT REQUIRED A REVISION KNEE REPLACEMENT TO A RIGHT TRIATHLON PS COMPONENT IMPLANTED IN 2005 DUE TO SUBSIDENCE AND LOOSENING OF THE COMPONENTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT KNEE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |