FDA Adverse Event
Malfunction
Summary report: N
REJUVENATE STEM INSERTER
MDR report key: 1933327
·
Received December 14, 2010
Report
- Report Number
- 2249697-2010-01733
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THERE IS A COLLETT ON THE END OF THIS INSERT THAT APPEARS TO BE BENT. INSERTER HANDLE WOULD NOT FULLY ENGAGE INTO THE STEM. MANAGED TO GET THE STEM IN USING IT AND FINISHING WITH THE FINISHING INSERTER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STEM INSERTER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | B3AEZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |