FDA Adverse Event
Injury
Summary report: N
TRIDENT CERAMIC ON CERAMIC HIP / HEMISPHERICAL
MDR report key: 1578229
·
Received January 12, 2010
Report
- Report Number
- 9616680-2010-00024
- Event Type
- Injury
- Date Received
- January 12, 2010
- Date of Event
- December 28, 2009
- Report Date
- December 28, 2009
- Manufacturer
- STRYKER ORTHOPAEDIC CORK
- Product Code
- MEH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "THE PATIENT UNDERWENT HIP REPLACEMENT SURGERY IN 2004 AND DECEMBER 25, 2005". IT WAS FURTHER REPORTED THAT, "AFTER IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN, CONSTANT IRRITATION AND DISCOMFORT IN THE AREA OF HER HIP".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT CERAMIC ON CERAMIC HIP / HEMISPHERICAL | IMPLANT | MEH | STRYKER ORTHOPAEDIC CORK | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |