FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #2
MDR report key: 2922112
·
Received January 11, 2013
Report
- Report Number
- 9616680-2013-90104
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 18, 2012
- Manufacturer
- STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, 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 PATIENT WAS BROUGHT IN FOR REVISION SURGERY DUE TO WHAT WAS THOUGHT TO BE AN INFECTION. DURING THE REVISION SURGERY, WHEN THE HEAD WAS REMOVED FROM THE STEM, THE SURGEON COMMENTED ON A GREY STAINING AROUND THE TRUNION AND WHAT APPEARED TO BE METAL DEBRIS SURROUNDING THE AREA. THE INTRAOPERATIVE LABS DID NOT CONFIRM AN INFECTION, THE SURGEON THEREFORE DID A SINGLE STAGE REVISION WITH AN ACCOLADE STEM AND EXCHANGED THE LINER WITH A NEW X3 LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18155 | ACCOLADE PLUS TMZF HIP STEM #2 | IMPLANT | MEH | STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI | NA | 38712502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other| R |