FDA Adverse Event
Injury
Summary report: N
TRIDENT CERAMIC LINER
MDR report key: 1000190
·
Received February 19, 2008
Report
- Report Number
- 9616680-2008-00030
- Event Type
- Injury
- Date Received
- February 19, 2008
- Date of Event
- January 21, 2008
- Report Date
- January 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MRA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED ON BEHALF OF THE SURGEON, THAT THE TRIDENT CERAMIC LINER CRACKED. IT IS FURTHER REPORTED THAT FOLLOWING AN ARTICLE IN THE CORK EXAMINER NEWSPAPER AND INFORMATION ON THE FDA WEBSITE, THE PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT CERAMIC LINER | IMPLANT | MRA | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |