FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR CEMENTED #3 FEMORAL COMPONENT
MDR report key: 2021329
·
Received March 8, 2011
Report
- Report Number
- 2249697-2011-00280
- Event Type
- Injury
- Date Received
- March 8, 2011
- Date of Event
- May 24, 2010
- Report Date
- February 11, 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
- KY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT: #3 TIBIAL COMPONENT; CAT # UNK, LOT # UNK, 11MM CS POLYETHLENE LINER; CAT # UNK, LOT # UNK, 10MM PATELLA COMPONENT; CAT # UNK, LOT # UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S SWELLING AND PAIN. AN EVAL OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SWELLING AND PAIN IN HER ANKLE. WOULD LIKE TO KNOW IF HER KNEE WAS PART OF THE STRYKER RECALL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR CEMENTED #3 FEMORAL COMPONENT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |