FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 1910451
·
Received November 23, 2010
Report
- Report Number
- 2249697-2010-01619
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- 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 RETAINED BY THE PT AND NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) 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 HAD A PRIMARY TKA PERFORMED ON (B)(6) 2010. HE HAD A "REACTION" AND HIS SURGICAL SITE WAS "RED & PUFFY." THE SURGEON DECIDED TO DO R & D TWO AND WASHED OUT THE SITE. HE DECIDED TO ALSO REPLACE ONLY THE TIBIAL INSERT, SAME SIZE THAT WAS IN THERE. ROUTINE AND UNEVENTFUL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | DTWMNA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |