FDA Adverse Event
Injury
Summary report: N
UNKNOWN_KIE_PRODUCT
MDR report key: 3132160
·
Received May 29, 2013
Report
- Report Number
- 0009610622-2013-00286
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 1, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
PATIENT IS A POST HIP FRACTURE FROM 2011 USING GAMMA 3 NAIL. NOW PRESENTS WITH DEGENERATIVE JOINT OF THE HIP. NAIL WAS REMOVED USING THE APPROPRIATE EXTRACTION INSTRUMENTS. SURGEON IMPLANTED A TRIDENT CUP AND A RESTORATION MODULE PER STANDARD SURGICAL PROTOCOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234988 | UNKNOWN_KIE_PRODUCT | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |