FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT ABGII HIP
MDR report key: 2821418
·
Received October 23, 2012
Report
- Report Number
- 9616680-2012-00917
- Event Type
- Injury
- Date Received
- October 23, 2012
- Date of Event
- February 22, 2011
- Report Date
- October 2, 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
- FL, 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 IS REPORTED THAT THE PATIENT IS EXPERIENCING DISCOMFORT WHILE EXERCISING. PATIENT IS ALSO EXPERIENCING PERIODIC DISCOMFORT AND SPORADIC ACHINESS ON THIGH AND HIP AREA. BLOOD TESTS AND BLOOD WORK PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT ABGII HIP | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |