FDA Adverse Event
Injury
Summary report: N
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
MDR report key: 12646612
·
Received October 18, 2021
Report
- Report Number
- 0002249697-2021-01716
- Event Type
- Injury
- Date Received
- October 18, 2021
- Date of Event
- August 27, 2021
- Report Date
- October 18, 2021
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- UDI-DI
- 07613327050318
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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
IT WAS REPORTED VIA MEDWATCH REPORT 5103633: PATIENT RECEIVED A LEFT AND RIGHT STRYKER TRIATHLON TOTAL KNEE IN 2019. PATIENT COMPLAINED OF PAIN IN 2020 WHICH PROGRESSIVELY WORSENED. LEFT KNEE IMPLANT WAS REOPERATED ON (B)(6) 2021. THE INTEROPERATIVE LAB RESULTS RULED OUT ANY INFECTION. IT WAS DISCOVERED THAT THE BONE CEMENT DID NOT BOND TO THE UNDERSIDE OF THE TIBIAL COMPONENT. THE TIBIAL IMPLANT WAS GROSSLY LOOSE. THIS IS NOT SUPPOSED TO OCCUR AND I AM REPORTING. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1545752 | TRIATHLON PRIM TIB BASEPLATE - CEMENTED | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | 5520-B-300 | EAO7BB | 07613327050318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |