FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 37.5MM NO 0
MDR report key: 2012949
·
Received March 2, 2011
Report
- Report Number
- 9616680-2011-00095
- Event Type
- Injury
- Date Received
- March 2, 2011
- Date of Event
- November 8, 2010
- Report Date
- February 15, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA SALES REP THAT PT HAD A PRIMARY IMPLANT SURGERY ON (B)(6) 2007 WHICH COMPLETED SUCCESSFULLY. CUSTOMER FURTHER REPORTED VIA THE SALE REP THAT THE STEM SNAPPED WHILE IN THE PT ON (B)(6) 2010 AND REVISION SURGERY HAD TO BE DONE ON (B)(6) 2010. CUSTOMER FURTHER ADDED VIA THE SALES REP THAT THE PT IS NORMALLY ACTIVE AND MOBILE, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 37.5MM NO 0 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | G1576010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |