FDA Adverse Event
Injury
Summary report: N
X3 TRIATHLONG CS INSERT #5 11MM
MDR report key: 2202557
·
Received August 8, 2011
Report
- Report Number
- 9610726-2011-00283
- Event Type
- Injury
- Date Received
- August 8, 2011
- Date of Event
- July 26, 2011
- Report Date
- July 26, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K063423
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT WAS EXPERIENCING INSTABILITY. SURGEON BROUGHT PT TO OPERATING ROOM. AFTER TRIALING AND EXAMINATION, SURGEON REPLACED 11MM POLY WITH 19MM POLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X3 TRIATHLONG CS INSERT #5 11MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LBX079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |