MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 CR INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-P-309
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision triathlon insert implanted 2007.Surgeon stated patient presented with instability he removed original insert and replaced with a triathlon cs 14mm insert.
Additional Manufacturer Narrative
Reported event: an event regarding instability and damage involving a triathlon insert was reported.The event was confirmed only for damage based on inspection.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2021.This inspection indicated the returned tibial insert is shown in figures 1-8.Backside impressions were observed on the distal surface of insert which are consistent with contact against the tibial base plate (figure2).Damage was observed on the articulating surface of the insert (figures 3 and 5) which is consistent with contact against the femoral component.The damage present on the articulating surface is consistent with burnishing and scratching (figures 4 and 6); these are common damage modes of uhmwpe (reference 1).Yellow discoloration consistent with absorption of synovial fluid was observed (reference 2).Damage consistent with material loss due to delamination was observed on the posterior aspect of the medial condyle (figure8).Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: the damage on the articulating surface of the insert was consistent with burnishing and scratching; which are common damage modes of uhmwpe.Damage consistent with material loss due to delamination was observed on the posterior aspect of the medial condyle.Yellow discoloration consistent with synovial fluid absorption was observed on the tibial insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 20 june 2007 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that triathlon insert was revised due to instability.The event was confirmed only for damage based on inspection.Material analysis: the damage on the articulating surface of the insert was consistent with burnishing and scratching; which are common damage modes of uhmwpe.Damage consistent with material loss due to delamination was observed on the posterior aspect of the medial condyle.Yellow discoloration consistent with synovial fluid absorption was observed on the tibial insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root 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.
Event or Problem Description
Revision triathlon insert implanted 2007.Surgeon stated patient presented with instability he removed original insert and replaced with a triathlon cs 14mm insert.

• Brand Name: TRIATHLON #3 CR INSERT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10654375
• Report Number: 0002249697-2020-02075
• Device Sequence Number: 14239371
• Product Code: MBH
• UDI-Device Identifier: 07613327041712
• UDI-Public: 07613327041712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 06/30/2012
• Device Model Number: 5530-P-309
• Device Catalogue Number: 5530P309
• Device Lot Number: LAT111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 03/08/2021
• 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