MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5520-B-600
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
An event regarding pain involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted medical records received and evaluation: a review of the provided medical records 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 exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If the product is returned, this investigation will be re-opened.
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.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 8558085
• Report Number: 0002249697-2019-01744
• Device Sequence Number: 2458296
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• 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
• Report Date (Section B): 04/26/2019

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: 01/31/2022
• Device Catalogue Number: 5520-B-600
• Device Lot Number: YGYOA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/26/2019
• 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