FDA Adverse Event
Injury
Summary report: N
HEAD FOR ENDOPROSTHESIS
MDR report key: 2010642
·
Received February 24, 2011
Report
- Report Number
- 9616680-2011-00089
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 11, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR #: 9616680-2011-00088. 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 THAT "WHEN THEY OPENED THE PACKAGING OF THE PRIMARY PRODUCT, LIQUID WAS NOTICED. ANOTHER LOT OF THE SAME CATALOGUE NUMBER WAS PRESENT AND THEY NOTICED ALSO LIQUID INSIDE WITHOUT OPENING IT. AS NO OTHER PRODUCTS OF THIS CATALOGUE NUMBER WERE AVAILABLE (SIZE 46), THEY IMPLANTED A DEVICE WITH INFERIOR SIZE (SIZE 44.5)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEAD FOR ENDOPROSTHESIS | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | G3044355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |