FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - GMRS PROXIMAL FEMORAL
MDR report key: 2801445
·
Received October 17, 2012
Report
- Report Number
- 9610726-2012-00329
- Event Type
- Injury
- Date Received
- October 17, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 26, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, UPON INSERTION OF PROXIMAL FEMUR CONSTRUCT, THERE WAS A DISTAL FEMORAL FRACTURE WITH THE DISTAL STEM PERFORATING THE ANTERIOR CORTEX OF THE DISTAL FEMUR. THIS REQUIRED A DISTAL FEMORAL KNEE REPLACEMENT WHICH WAS AVAILABLE BUT THE TIBIAL ROTATING HINGE KNEE INSTRUMENTS WERE NOT AVAILABLE SO THE PATIENT WAS SCHEDULED FOR DISTAL FEMORAL KNEE REPLACEMENT SURGERY ON (B)(6). THAT SURGERY WENT WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - GMRS PROXIMAL FEMORAL | IMPLANT | KWY | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |