FDA Adverse Event
Injury
Summary report: N
UNK RIGHT ABG II NECK
MDR report key: 2912800
·
Received January 7, 2013
Report
- Report Number
- 9616680-2013-90030
- Event Type
- Injury
- Date Received
- January 7, 2013
- Date of Event
- September 27, 2011
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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 HAD BILATERAL HIP IMPLANTS. SHE RECEIVED LETTERS ABOUT RECALLED HIPS. THE PT IS REPORTING THAT SHE HAS PAIN IN HER RIGHT HIP AND SOMETIMES HER HIP DOESN'T HOLD HER WEIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8544 | UNK RIGHT ABG II NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |