FDA Adverse Event
Injury
Summary report: N
TRIDENT CERAMIC ON CERAMIC HIP
MDR report key: 1911238
·
Received November 23, 2010
Report
- Report Number
- 9616680-2010-00758
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- November 9, 2010
- Report Date
- November 9, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFO 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, "IT WAS REPORTED THAT "THE PT UNDERWENT HIP REPLACEMENT SURGERY ON OR ABOUT (B)(6) 2006". IT WAS FURTHER REPORTED THAT, "AFTER IMPLANTATION, THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN, CONSTANT IRRITATION AND DISCOMFORT IN THE LOCATION OF HER HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT CERAMIC ON CERAMIC HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |