FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER TRIATHLON CR KNEE
MDR report key: 10513132
·
Received September 10, 2020
Report
- Report Number
- 0002249697-2020-01827
- Event Type
- Injury
- Date Received
- September 10, 2020
- Date of Event
- March 1, 2015
- Report Date
- September 10, 2020
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.
Description of Event or Problem · 1
THIS PI IS FOR PATIENT 2 OF 11. IN AN EXCERPT FROM THE 2018 DKG ANNUAL MEETING, "CRUCIATE RETAINING VERSUS POSTERIOR STABILIZED TOTAL KNEE ARTHROPLASTY FOR THE TREATMENT OF VALGUS OSTEOARTHRITIS?" THE FOLLOWING IS NOTED: "IN THE CR GROUP, 11/97 PATIENTS WERE REVISED DUE TO A.P. INSTABILITY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 981915 | UNKNOWN STRYKER TRIATHLON CR KNEE | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |