FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM#5
MDR report key: 2821320
·
Received October 17, 2012
Report
- Report Number
- 9616680-2012-00895
- Event Type
- Injury
- Date Received
- October 17, 2012
- Date of Event
- September 25, 2012
- Report Date
- September 25, 2012
- 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
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 PATIENT HAD HIP PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM#5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 12431001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other| R |