FDA Adverse Event
Other
Summary report: N
UNK PRODUCT - TRIDENT CERAMIC ON CERAMIC HIP
MDR report key: 1575009
·
Received January 7, 2010
Report
- Report Number
- 9616680-2010-00007
- Event Type
- Other
- Date Received
- January 7, 2010
- Date of Event
- December 16, 2009
- Report Date
- December 16, 2009
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADD'L 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: "THE PT UNDERWENT HIP REPLACEMENT SURGERY ON (B)(6) 2005. IT WAS FURTHER REPORTED THAT 'AFTER IMPLANTATION THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN, CONSTANT IRRITATION AND DISCOMFORT IN THE AREA OF HER HIP". FURTHER, IT IS ALLEGED THAT THE PT'S DEFECTIVE DEVICE WAS RECALLED BY STRYKER (B)(4) ON (B)(4) 2008 DUE TO THE DETECTION OF "MANUFACTURING RESIDUALS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK PRODUCT - TRIDENT CERAMIC ON CERAMIC HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |