FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR X3 TIBIAL INSERT
MDR report key: 1053363
·
Received May 28, 2008
Report
- Report Number
- 9610726-2008-00024
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- December 20, 2007
- Report Date
- May 7, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSH
- PMA / PMN Number
- 051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CLINICAL RESEARCH MANAGER WAS INFORMED OF AN SERIOUS ADVERSE EVENT THAT OCCURRED IN LATE 2007. A PATIENT INVOLVED IN A CLINICAL STUDY EXPERIENCED DEEP INFECTION AFTER IMPLANTATION OF TRIATHLON. THE PATIENT HAD REVISION SURGERY. ACCORDING TO THE SERIOUS ADVERSE EVENT REPORT, THE PATIENT IS COMPLETELY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR X3 TIBIAL INSERT | IMPLANT | HSH | STRYKER ORTHOPAEDICS LIMERICK | NA | LAT885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |