FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT HIP NECK
MDR report key: 2910437
·
Received January 4, 2013
Report
- Report Number
- 9616680-2013-90024
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- October 27, 2011
- Report Date
- December 14, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- 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. 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 PT IS EXPERIENCING PAIN IN HER RIGHT LEG. THE PT STATES THAT SHE HAD X-RAYS AND BLOOD WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5522 | UNKNOWN RIGHT HIP NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other |