FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 44MM NO 0
MDR report key: 2922087
·
Received January 11, 2013
Report
- Report Number
- 9616680-2013-90096
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 19, 2012
- Manufacturer
- STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
- Product Code
- LZO
- PMA / PMN Number
- K011632
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
SALES REP REPORTED ON BEHALF OF THE SURGEON THAT AN EXETER STEM FRACTURED ABOUT 1 YEAR AFTER IMPLANTATION. IT WAS REVISED ON THE (B)(6) 2012. FURTHER INFO RECEIVED ON (B)(6) 2012 INDICATED THAT A STEM-GRAFT AND CEMENT WERE REMOVED, A LONG UNCEMENTED ZWEYMULLER IMPLANT WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17979 | EXETER V40 STEM 44MM NO 0 | IMPLANT | LZO | STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |