FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR X3 TIBIAL INSERT
MDR report key: 1982236
·
Received January 24, 2011
Report
- Report Number
- 2249697-2011-00091
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- January 8, 2011
- Report Date
- January 8, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE ABOVE LISTED X3 CR TIBIAL INSERT #5 9MM (LOT MHP39P) WAS REMOVED AND REPLACED WITH A 5531-G-513 X3 CS TIBIAL INSERT 35 13MM DUE TO INSTABILITY OF THE KNEE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | MHP39P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |