FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT HIP NECK
MDR report key: 2893481
·
Received December 21, 2012
Report
- Report Number
- 9616680-2012-01485
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- June 1, 2010
- Report Date
- December 3, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 CURRENTLY EXPERIENCING PAIN. THE PT HAD WENT TO SEE HER SURGEON AND HAD TESTS DONE. THE SURGEON STATES THAT PT NEEDS REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT HIP NECK | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other| R |