FDA Adverse Event
Injury
Summary report: N
UNKNOWN ACCOLADE (127 DEG) SIZE 3.5
MDR report key: 2210073
·
Received August 3, 2011
Report
- Report Number
- 9616680-2011-00515
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "REVISION BECAUSE STEM WAS LOOSE. PT WAS FEELING PAIN AND MOVEMENT IN HER HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ACCOLADE (127 DEG) SIZE 3.5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 18576302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |