FDA Adverse Event
Malfunction
Summary report: N
EXETER CONTEMPORARY. CUP
MDR report key: 2051483
·
Received April 4, 2011
Report
- Report Number
- 9616680-2011-00164
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- January 3, 2011
- Report Date
- March 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED, "ACCORDING TO THE NURSE, THERE WAS A HAIR INSIDE THE IMPLANT BOX."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER CONTEMPORARY. CUP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | G3012402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |