FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE STEM INSERTER/EXTRACTOR
MDR report key: 2945258
·
Received December 21, 2012
Report
- Report Number
- 2249697-2012-02759
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 WHILE EXTRACTING THE STEM WITH INSERTER AND SLAP HAMMER ATTACHED, THE END OF THE ACCOLADE SCREW ON INSERTER BECAME DETACHED. AT THIS POINT THE STEM WAS OUT FOR ENOUGH TO GET OUT. A BIOMET TEMPORARY PROSTALAC HIP TEMPORARY SPACER WAS INSERTED. RETURNING THE HANDLE AND IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE STEM INSERTER/EXTRACTOR | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other |