FDA Adverse Event
Injury
Summary report: N
HOW ROT HNG KNEE FEM M LFT
MDR report key: 758754
·
Received September 7, 2006
Report
- Report Number
- 9610726-2006-00047
- Event Type
- Injury
- Date Received
- September 7, 2006
- Date of Event
- August 17, 2006
- Report Date
- August 17, 2006
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT MFG IN THE US. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
BREAKAGE OF THE FEMORAL COMPONENT WAS REPORTED. THE BREAKAGE OCCURRED IN THE AREA OF THE THREADED HOLE FOR THE DISTAL AUGMENTATION BLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOW ROT HNG KNEE FEM M LFT | IMPLANT | HSA | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |