FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 50MM NO 1
MDR report key: 2243817
·
Received September 6, 2011
Report
- Report Number
- 9616680-2011-00588
- Event Type
- Injury
- Date Received
- September 6, 2011
- Date of Event
- August 19, 2011
- Report Date
- August 19, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K891454
- 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 EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SALES REP REPORTED A REVISION HIP REPLACEMENT. HE EXPLAINED THAT THE PT WAS REVISED FOR GENERAL PAIN AND THAT THE JOINT WAS SWOLLEN. HE ADDED THAT DUE TO THIS THE SURGEON HAD TO DRAIN TWO LITERS OF FLUIDS FROM THE JOINT. HE ALSO ADDED THAT THE DATE OF THE INITIAL SURGERY WAS (B)(6) 2003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 50MM NO 1 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | GB16427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |