FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE STEM INSERTER
MDR report key: 1850042
·
Received September 27, 2010
Report
- Report Number
- 2249697-2010-01275
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 3, 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
- NJ, 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, "AFTER TRAILING, ATTACHED THE INSERTER TO THE ACCOLADE HFX #4 STEM AND PROCEEDED TO IMPACT THE STEM. THE PA NOTICED TWO VERY SMALL PIECES OF METAL SHAVINGS THAT CHIPPED AWAY AND FELL INTO THE PATIENT, FROM THE INSERTER. THEY COMPLETED THE IMPLANTED OF THE STEM, AND THEN PULLED OUT THE INSERTER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE STEM INSERTER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | BPZW04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |