MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B300

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. 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.

Event Description

The patient is a subject in the triathlon tritanium knee outcomes study. All of the following information is per the operative note. The patient had continued pain in her right (operative) knee and failed conservative measures to resolve it. X-rays revealed "aseptic loosening and catastrophic failure of the tibial component, drifting into varus. " the surgeon's postprocedural diagnosis is "right total knee arthroplasty failure. This is a failed pressfit design with aseptic loosening of the tibia with a tibial fracture from mechanical failure. " operative report notes a significant amount of varus. Revision components included cancellous screws with a cemented tibial component.

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7716590
• MDR Text Key: 114933829
• Report Number: 0002249697-2018-02283
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,OTHER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/24/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2019
• Device Catalogue Number: 5536B300
• Device LOT Number: CTD3226
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/14/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 07/24/2018 Patient Sequence Number: 1