FDA Adverse Event
Injury
Summary report: N
NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
MDR report key: 2801405
·
Received October 17, 2012
Report
- Report Number
- 2249697-2012-01912
- Event Type
- Injury
- Date Received
- October 17, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K072221
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENT REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DR. (B)(6) HAD PREVIOUSLY WORKED ON HER AND SHE HAS HAD REOCCURRING ISSUES WITH HER KNEE. DR. (B)(6) REVISED HER TO A THICKER POLYETHYLENE SPACER AND SHE APPEARED TO BE MORE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | JV4MMD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |