FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT HIP NECK
MDR report key: 2893483
·
Received December 21, 2012
Report
- Report Number
- 9616680-2012-01481
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
- 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 PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADD¿L 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 PATIENT SOMETIMES EXPERIENCES PAIN IN HER HIP. THE PATIENT HAS RECEIVED LETTER BUT HAS NOT SPOKEN WITH HER SURGEON SINCE RECEIVING LETTER. THE PATIENT DID NOT WANT TO OFFER ANY INFO REGARDING HER HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT HIP NECK | IMPLANT | JDI | STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |