MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B600

Device Problem Failure to Osseointegrate (1863)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? not returned to the manufacturer.

Event Description

As reported: ".Patient is 3 year post primary left tka.Doctor told me that the patient has had pain and recurrent effusions and his imaging studies suggest a loose tibial component.The patient was scheduled for surgery on (b)(6) 2019.Doctor used an osteotome circumferentially around the tibial component to loosen the tibial baseplate [revision operative report states "i was able to place an osteotome beneath the component between the bone and implant.This was a press-fit implant originally.Was able to get the osteotome underneath the component nearly all the way around and then it easily lifted up.It was clearly not well fixed.There was no bone loss during the removal."].He inspected the other implants and said after surgery they appeared to be well fixed.He did a tibial clean up cut and prepped for a universal cemented baseplate and 12x50 stem.He trialed a 16mm ps poly trial and asked for the actual implant.There will be no explants because they were discarded by the hospital.

• Brand Name: TRITANIUM BPLATE TRIATHLON S6
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9347931
• MDR Text Key: 167184027
• Report Number: 0002249697-2019-03829
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• 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: Physician
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD10601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR