FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3781242
·
Received April 30, 2014
Report
- Report Number
- 0002249697-2014-01644
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 10, 2014
- Report Date
- April 10, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN SIZE 50 PSL CLUSTER HOLE CUP. THE DEVICE WAS REPORTEDLY DISCARDED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DISCARDED.
Description of Event or Problem · 1
THE PATIENT'S LEFT HIP WAS BEING REVISED DUE TO THE CUP HAVING PROTRUSION THROUGH THE ACETABULUM. THE PATIENT HAD PREVIOUSLY BEEN CONVERTED FROM UNKNOWN TRAUMA DEVICES TO A TOTAL HIP. NO FURTHER INFORMATION WILL BE MADE AVAILABLE TO THE SALES REP FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259099 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | KWY | STRYKER ORTHOPAEDICS-MAHWAH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other| R |