FDA Adverse Event
Malfunction
Summary report: N
UNK PRODUCT
MDR report key: 1542102
·
Received November 4, 2009
Report
- Report Number
- 2249697-2009-00761
- Event Type
- Malfunction
- Date Received
- November 4, 2009
- Date of Event
- October 6, 2009
- Report Date
- October 6, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICE IS NOT AVAILABLE DUE TO THE ONGOING LITIGATION. SHOULD DEVICE OR ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PT ALLEGES FAILURE OF HIS HIP PROSTHESIS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |