FDA Adverse Event
Summary report: N
EXP ACETABULAR SHELL AND LINER
MDR report key: 4954291
·
Received July 30, 2015
Report
- Report Number
- 2530191-2015-00021
- Date Received
- July 30, 2015
- Date of Event
- July 2, 2015
- Report Date
- July 30, 2015
- Manufacturer
- STELKAST, INC.
- Product Code
- OQI
- PMA / PMN Number
- K094035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SHOWS THAT NO MATERIAL PROPERTY, MECHANICAL, OR DIMENSIONAL DISCREPANCIES EXISTED IN THIS LOT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
PATIENT DISLOCATED IN RECOVERY. THE SURGEON'S OPINION IS THAT HE DID NOT ALLOW FOR ENOUGH ANTEVERSION - CORRECTED WITH HOODED LINER. THE ORIGINAL STEM, HEAD AND LINER WERE ALSO REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497453 | EXP ACETABULAR SHELL AND LINER | 36MM COCR FEMORAL HEAD | OQI | STELKAST, INC. | SC3261-36MM +7 | 26414-070611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |