FDA Adverse Event
Injury
Summary report: N
ACCOLADE 132 SIZE 4.5
MDR report key: 1915779
·
Received November 29, 2010
Report
- Report Number
- 9616680-2010-00772
- Event Type
- Injury
- Date Received
- November 29, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "ACCOLADE STEM WAS GROSSLY LOOSE. SURGEON REVISED IT WITH RESTORATION MOD STEM +40 MM AND HEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE 132 SIZE 4.5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 31123302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |