FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 4093893
·
Received September 16, 2014
Report
- Report Number
- 0002249697-2014-03507
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- May 8, 2013
- Report Date
- August 26, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER IS UNKNOWN AT THIS TIME. DEVICE DESCRIPTION WAS REPORTED AS UNKNOWN ACETABULAR LINER. IN ADDITION TO THE LINER, AN UNKNOWN V40 FEMORAL HEAD WAS ALSO REPORTED. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH THE FILING A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS AGAIN REVISED ON (B)(6) 2014. "THE PREOPERATIVE DIAGNOSIS WAS INFECTED RIGHT TOTAL HIP REPLACEMENT, DRAINING SINUS, AS WELL AS SYNOVITIS, COMPLEX WOUND, HIP AND NONVIABLE BONE, FEMUR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571007 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |