FDA Adverse Event
Injury
Summary report: N
TITANIUM FEMORAL STEM
MDR report key: 648827
·
Received November 21, 2005
Report
- Report Number
- 2249697-2005-00131
- Event Type
- Injury
- Date Received
- November 21, 2005
- Date of Event
- January 5, 2005
- Report Date
- October 31, 2005
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
"PATIENT REPORTED HAVING "ISSUES" WITH HIS HIP, REQUIRING MULTIPLE SURGERIES. HE REPORTED HAVING HIS RIGHT HIP REPLACED IN 2000, FOLLOWED BY A REVISION IN 2003. IN 2003, HE REPORTED THAT IT WAS A STRYKER IMPLANT (WITH A TITANIUM FEMORAL STEM). HE CLAIMS THAT HE HAD TO HAVE THE STRYKER STEM REVISED IN 2005 BECAUSE THE FEMORAL PIECE FRACTURED. PRODUCT IDENTIFICATION AND MEDICALS ARE PENDING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITANIUM FEMORAL STEM | IMPLANT | JDD | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |