FDA Adverse Event
Injury
Summary report: N
ACCOLADE HFX STEM SIZE 4
MDR report key: 1243830
·
Received November 24, 2008
Report
- Report Number
- 2249697-2008-00374
- Event Type
- Injury
- Date Received
- November 24, 2008
- Date of Event
- October 30, 2008
- Report Date
- October 30, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHAWAH
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THEY BROACHED TO A NUMBER 6, INSERTED #6 IMPLANT AND FRACTURED THE FEMUR AS A RESULT THEY CEMENTED A #4."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE HFX STEM SIZE 4 | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHAWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |