FDA Adverse Event
Death
Summary report: N
UNKNOWN STRYKER HIP DEVICE
MDR report key: 2817457
·
Received October 25, 2012
Report
- Report Number
- 2249697-2012-02085
- Event Type
- Death
- Date Received
- October 25, 2012
- Date of Event
- January 1, 2009
- Report Date
- October 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE DEVICE IS NOT AVAILABLE DUE TO THE ONGOING LITIGATION. SHOULD DEVICE OR ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT IS ALLEGED THROUGH THE FILLING OF A LAWSUIT THAT: THE PT REC'D A STRYKER HIP DEVICE ON OR ABOUT (B)(6) 2009 WHICH CAUSED HER INJURY AND ULTIMATE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER HIP DEVICE | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |