FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #6
MDR report key: 2885232
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01427
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- STRYKER ORHTOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON OPENED THE PT AND REMOVED THE STEM WHICH WAS LOOSE . HE CHECKED THE CUP AND FOUND IT TO BE WELL FIXED. HE THEN REIMPLANTED THE ABOVE MENTIONED COMPONENTS. THERE WAS NO EVIDENCE OF INFECTION PRIOR TO OR AT THE TIME OF THIS REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #6 | IMPLANT | MEH | STRYKER ORHTOPAEDICS CORK | NA | 30153002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |