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

Model Number	5530-G-411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional 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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of insert due to instability.
Event or Problem Description
Revision of insert due to instability.
Additional Manufacturer Narrative
Reported event; an event regarding instability and wear involving a triathlon insert was reported.The event of instability was not confirmed, while the event of wear was confirmed via evaluation of the returned device.Method & results: device evaluation and results: the device was returned for evaluation.Wear/damage is observed on the flange of the insert.A material analysis has been performed.The report concluded: the uhmwpe1 insert experienced an overload failure on one side of an anterior flange area after significant wear-related material removal.No material or manufacturing defects were found on the surfaces investigated.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total knee replacement at 7 years after implantation due to instability and possibly fracture of the polyethylene.I cannot confirm that this event took place since i was not able to view the explanted parts, nor a revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of late instability are multifactorial including patient factors such as weight and activity level, surgical technique factors such as proper ligament balancing, as well as possible trauma.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.  conclusion: it was reported that the patient's knee was revised due to instability.The device was returned for evaluation.Wear/damage is observed on the flange of the insert.The material analysis of the returned device concluded: the uhmwpe1 insert experienced an overload failure on one side of an anterior flange area after significant wear-related material removal.No material or manufacturing defects were found on the surfaces investigated.A review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total knee replacement at 7 years after implantation due to instability and possibly fracture of the polyethylene.I cannot confirm that this event took place since i was not able to view the explanted parts, nor a revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of late instability are multifactorial including patient factors such as weight and activity level, surgical technique factors such as proper ligament balancing, as well as possible trauma.The exact cause of the event could not be determined.Further information such as revision operative reports are required to confirm the instability and determine a route cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12002707
• Report Number: 0002249697-2021-01036
• Device Sequence Number: 3589033
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MNA2KJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 73 KG