FDA Adverse Event
Injury
Summary report: N
TRIATHLON TS BASEPLATE
MDR report key: 2221585
·
Received August 18, 2011
Report
- Report Number
- 2249697-2011-01217
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
PAIN, LOOSENING, NO INDICATION OF INFECTION. TRIATHLON KNEE IMPLANTED IN 2007. TIBIAL BASEPLATE AND INSERT REVISED DUE TO ASEPTIC LOOSENING. TRIATHLON TS BASEPLATE, STEM, INSERT AND AUGMENTS IMPLANTED DURING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON TS BASEPLATE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |