FDA Adverse Event
Injury
Summary report: N
ABG II, NO-HOLE CUP, HA O.D. 54MM FOR CERAMIC/CERAM
MDR report key: 2885242
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01438
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- August 1, 2012
- Report Date
- November 28, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
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 THAT A REVISION TOOK PLACE DUE TO A FRACTURED ALUMINA INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABG II, NO-HOLE CUP, HA O.D. 54MM FOR CERAMIC/CERAM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | GZ613129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |