FDA Adverse Event
Injury
Summary report: N
RIGHT HIP NECK
MDR report key: 2896169
·
Received December 28, 2012
Report
- Report Number
- 9616680-2012-01524
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- February 28, 2011
- Report Date
- December 13, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT IS EXPERIENCING PAIN AND HAVING A PROBLEM PLACING WEIGHT ON HER RIGHT LEG. PT IS ALSO REPORTING INFLAMMATION AND FLUID IN HER HIP AND AN ELEVATED COBALT LEVEL. PT STATES THAT SURGEON IS RECOMMENDING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT HIP NECK | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |