FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON-PS TIBIAL INSERT #6 - 11MM
MDR report key: 1870500
·
Received October 6, 2010
Report
- Report Number
- 9610726-2010-00344
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 16, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2010-00343.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON STATED WHEN HE IMPLANTED THE TIBIAL INSERT (ITEM # 5532-P-611 LOT: LBY033) IT SAT UP ON ONE SIDE AND THE METAL RING IN FRONT OF INSERT WOULD NOT LOCK. SURGEON OPENED A SECOND INSERT (ITEM # 5532-P-611 LOT: LBX029) WHICH DID LOCK IN FRONT BUT SAT UP 1MM ON THE SIDE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PS TIBIAL INSERT #6 - 11MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LBX029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |