FDA Adverse Event
Injury
Summary report: N
UNKNOWN TIBIAL INSERT
MDR report key: 2042248
·
Received March 29, 2011
Report
- Report Number
- 2249697-2011-00379
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICES CANNOT BE PERFORMED AS HOSPITAL NEEDS THEM FOR NOW AND THE DEVICES WERE 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. THIS IS THE SAME PT / EVENT AS: MFR # 2249697-2011-00378.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING REVISION SURGERY TO POSSIBLY EXCHANGE PT'S POLYETHYLENE INSERT, THE SURGEON DISCOVERED THAT THE FEMORAL COMPONENT WAS CRACKED INTO TWO PIECES AND THE TIBIAL INSERT WAS BRACKED AS WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |