FDA Adverse Event
Injury
Summary report: N
TRIATHLON P/A CR BEADED #7L
MDR report key: 2090843
·
Received May 12, 2011
Report
- Report Number
- 9610726-2011-00155
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- January 8, 2007
- Report Date
- January 8, 2007
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- MBH
- PMA / PMN Number
- K051380
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "LUCENCIES ON X-RAY OF THE FEMORAL COMPONENT. PATIENT HAVING PAIN MEDIAL SIDE OF THE LEFT KNEE AND AMBULATING WITH A KNEE IMMOBILIZER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON P/A CR BEADED #7L | IMPLANT | MBH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |