FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3781124
·
Received April 30, 2014
Report
- Report Number
- 0002249697-2014-01712
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 18, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN OMNIFLEX STEM. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION WILL BE MADE AVAILABLE FROM THE HOSPITAL DUE TO THEIR STRICT CONFIDENTIALITY POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON X- RAY, STEM MIGRATED. REVISION DONE ON RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259586 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | KWY | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |