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-609
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/03/2017
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
Patient called stating he had a right knee replacement done on (b)(6) 2017.Patient reported he has a clicking noise every time he walks.Update 29-mar-2019: as per medical records, the correct primary implant date is (b)(6) 2017.Patient was revised on (b)(6) 2018 due to clicking noise.The poly insert was revised.
Additional Manufacturer Narrative
An event regarding audible noise involving a triathlon insert was reported.The event was confirmed by medical review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information 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 and is reviewed in pi 2048363.Does the review identify any procedural related factors that contributed to the event? effective posterior tibial slope of the baseplate effective bearing thickness 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.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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.
Event or Problem Description
Patient called stating he had a right knee replacement done on (b)(6) 2017.Patient reported he has a clicking noise every time he walks.Update 29-mar-2019: as per medical records, the correct primary implant date is (b)(6) 2017.Patient was revised on (b)(6) 2018 due to clicking noise.The poly insert was revised.

• 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: 8499445
• Report Number: 0002249697-2019-01571
• Device Sequence Number: 16773180
• Product Code: MBH
• UDI-Device Identifier: 07613327050844
• UDI-Public: 07613327050844
• 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): 06/05/2019

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: 12/31/2012
• Device Catalogue Number: 5532-G-609
• Device Lot Number: N26M1T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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