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

Catalog Number	5532-G-611
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
This pi is for clicking noise and pain after revision.As per op report, patient is experiencing pain and clicking noise 2 weeks post revision.
Event or Problem Description
This pi is for clicking noise and pain after revision.As per op report, patient is experiencing pain and clicking noise 2 weeks post revision.
Additional Manufacturer Narrative
An event regarding range of motion issues, resulting in pain and a clicking sounds involving a triathlon insert was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: an adverse combination of procedure-related factors regarding optimal positioning of components to avoid post-cam impingement in a ps knee with some patient-related factors regarding individual anatomical variations has contributed to a certain laxity in the central compartment of the knee to allow repeated loss and regain of contact in the post-cam to generate clicking sounds during the various movements of the knee.Revision surgery was undertaken to replace the bearing with a thicker sample but this only solves part of the problem and thus the noise may persist after revision such as also occurred in this patient.Does the review identify any procedural related factors that contributed to the event? effective posterior tibial slope of the baseplate.Increasing bearing thickness during revision solves only a small part of the problem.Does the review identify any patient related factors that contributed to the event? a wide native condylar tunnel allows for more sideways movements than normal during knee movements.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.Device history review: all 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: the investigation concluded that an adverse combination of procedure-related factors regarding optimal positioning of components to avoid post-cam impingement in a ps knee with some patient-related factors regarding individual anatomical variations has contributed to a certain laxity in the central compartment of the knee to allow repeated loss and regain of contact in the post-cam to generate clicking sounds during the various movements of the knee.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8556845
• Report Number: 0002249697-2019-01734
• Device Sequence Number: 2103553
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 06/30/2022
• Device Catalogue Number: 5532-G-611
• Device Lot Number: 7R2M8A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100