FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #2
MDR report key: 2210085
·
Received August 3, 2011
Report
- Report Number
- 9616680-2011-00516
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 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
- MN, 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 THAT PT CAME FOR PRE-OP EVAL FOR REVISION TOTAL HIP PREVIOUS COMPLAINTS OF PAIN IN UPPER THIGH. USES CAN TO RELIEVE. FAILURE OF INGROWTH WITH SUBSIDENCE OF STEM. REVISION TO MOD RESTORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #2 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 10860701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |