FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT ABG II HIP STEM
MDR report key: 2911153
·
Received January 7, 2013
Report
- Report Number
- 9616680-2013-90029
- 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
- KWY
- 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
ADDITIONAL INFORMATION 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 HAD BILATERAL HIP IMPLANTS. SHE RECEIVED LETTERS ABOUT RECALLED HIPS. THE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 6647 | UNKNOWN RIGHT ABG II HIP STEM | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |