FDA Adverse Event
Injury
Summary report: N
UNK LEFT HIP ABGII STEM
MDR report key: 2912779
·
Received January 7, 2013
Report
- Report Number
- 9616680-2013-90016
- Event Type
- Injury
- Date Received
- January 7, 2013
- Date of Event
- September 1, 2010
- Report Date
- December 10, 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
- PA, 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 IS EXPERIENCING PAIN IN THE HIP JOINT AND IS HAVING DIFFICULTY WALKING AND GOING UP STAIRS. PT STATES THAT HE WILL NEED REVISION SURGERY AND IT IS SCHEDULED FOR (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7980 | UNK LEFT HIP ABGII STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other| R |