FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #5
MDR report key: 2182146
·
Received June 23, 2011
Report
- Report Number
- 9616680-2011-00421
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT WAS PREPPED FOR A #5. THE IMPLANT BOX STATES #5. WHEN THE STEM WAS PUT NEAR THE BROACH, IT SEEMED TOO SMALL. WE INSPECTED THE STEM AND IT WAS MARKED A #3. SO A #3 IMPLANT WAS PACKAGED IN A BOX MARKED FOR A #5."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 35202601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |