FDA Adverse Event
Injury
Summary report: N
X3 TRIATHLON CS INSERT #3 11MM
MDR report key: 2190412
·
Received July 28, 2011
Report
- Report Number
- 9610726-2011-00264
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 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
- FL, 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 (X-RAYS, MEDICAL RECORDS, OPERATIVE NOTES) 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 SUFFERED FROM PAIN AND JOINT LAXITY, SO SHE WAS REVISED TO A THICKER LINER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X3 TRIATHLON CS INSERT #3 11MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LAM367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |