FDA Adverse Event
Malfunction
Summary report: N
EXETER CONTEMPORARY. CUP
MDR report key: 2924008
·
Received December 14, 2012
Report
- Report Number
- 9616680-2012-01382
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT THE SPACER HAD COME OFF THE CUP. SHE EXPLAINED THAT THIS HAPPENED SHORTLY AFTER THEY OPENED THE PACKAGING BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AS AN ALTERNATIVE DEVICE WAS AVAILABLE IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER CONTEMPORARY. CUP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | G3186062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |