FDA Adverse Event
Injury
Summary report: N
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #6 RIGHT
MDR report key: 1833116
·
Received September 9, 2010
Report
- Report Number
- 9610726-2010-00294
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- March 4, 2008
- Report Date
- August 24, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SIGNS/SYMPTOMS/DISEASES BEING REPORTED: SWELLING IN RIGHT KNEE. RELATED TO DEVICE = UNCERTAIN. CHRONIC EFFUSION OF RIGHT KNEE. TREATMENT - STRENGTHENING EXERCISES. RESOLUTION OF EVENT AS OF (B)(6) 2008 = UNRESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-CR FEMORAL COMPONENT CEMENTED #6 RIGHT | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SB49F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |