MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-311

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to wear involving a triathlon insert was reported.The event was confirmed through visual inspection of the photographs provided.Method and results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs provided show a recently explanted insert with significant damage in one compartment on the anterior aspect.There is what appears to be a piece of the anterior face of insert partially removed but remains attached at one end on the side of the component.Medical records received and evaluation: clinician review of the medical records provided concluded massive obesity of the patient was clearly an important factor to contribute to instability failure of the right knee arthroplasty after some 10-years of use.Whether other contributing factors were present cannot be determined due to lack of relevant radiological information.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the reported event relates to revision due to insert wear after approximately 10 years in vivo.The photographs of the explanted poly components confirm wear of insert and patella.Clinician review of the medical records provided concluded massive obesity of the patient was clearly an important factor to contribute to instability failure of the right knee arthroplasty after some 10-years of use.Whether other contributing factors were present cannot be determined due to lack of relevant radiological information.No further investigation for this event is possible at this time.Product surveillance will continue to monitor for trends.

Event Description

It was reported that patient's right knee was revised due to deformity and pain.An office note provided mentions a concern that metal debris might build up in the knee with what "appears to be complete loss of clear space medially".The insert and patella were revised.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7549305
• MDR Text Key: 109399087
• Report Number: 0002249697-2018-01611
• 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: Physician
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 5530-G-311
• Device Lot Number: 234MHE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2008
• 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: 53 YR
• Patient Weight: 169