FDA Adverse Event
Injury
Summary report: N
EXETER V40 STEM 37.5MM NO 0
MDR report key: 722267
·
Received May 31, 2006
Report
- Report Number
- 9610669-2006-00004
- Event Type
- Injury
- Date Received
- May 31, 2006
- Date of Event
- May 12, 2006
- Report Date
- May 17, 2006
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT PRESENTED WITH ACUTE PAIN IN MAY WHICH STARTED AS THEY WERE GETTING OUT OF BED. IT WAS FURTHER REPORTED THAT XRAYS TAKEN SUGGESTED THAT THE IMPLANT HAD BENT, BUT DURING THE PROCEDURE IN 2006, IT WAS DISCOVERED THAT THE THREE YEAR OLD STEM HAD FRACTURED AT THE NECK, AND THE STEM AND HEAD WERE THEREFORE REVISED. THE PATIENT'S MEDICAL RECORDS DETAIL THE STEM AND HEAD AS STRYKER PRODUCTS BUT THE CUP IS A DE PUY ULTIMA PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 37.5MM NO 0 | IMPLANT | KWY | STRYKER ORTHOPAEDICS CAEN | NA | GA681397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |