FDA Adverse Event
Injury
Summary report: N
UNKNOWN_ACCOLADE II #5 STEM
MDR report key: 6039984
·
Received October 19, 2016
Report
- Report Number
- 0002249697-2016-03253
- Event Type
- Injury
- Date Received
- October 19, 2016
- Date of Event
- September 20, 2016
- Report Date
- September 20, 2016
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KWL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
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 ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
PATIENT HAD A PERI PROSTHETIC HIP FRACTURE OF THE PROXIMAL LEFT FEMUR DUE TO FALL. HIP STEM WAS REMOVED ALONG WITH CERAMIC HEAD. FRACTURE WAS REDUCED AND NEW RESTORATION MODULAR STEM AND BIOLOX HEAD WERE IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691682 | UNKNOWN_ACCOLADE II #5 STEM | HIP IMPLANT | KWL | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |