MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-413
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Update: the reason for revision was ¿poly wear.¿.
Additional Manufacturer Narrative
Reported event: an event regarding wear, instability and dislocation/subluxation involving a triathlon insert was reported.The event of wear was confirmed through material analysis of the returned device.Review of the provided medical records also indicated malposition of the femoral component which was confirmed through x-rays.Instability and dislocation/subluxation were not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).This inspection indicated: damage was observed on the distal and anterior surfaces of the insert which is consistent with the explantation process.Backside impressions on the distal surface of insert are consistent with contact against a tibial base plate.Damage was observed on the articulating surface of the insert which is consistent with contact against the femoral component.The damage present on the articulating surface is consistent with burnishing and scratching these are common damage modes of uhmwpe.Damage consistent with delamination and material loss due to articulation against the femoral component was observed on the posterior portion of the medial condyle.A material analysis has been performed.The report concluded:the damage present on the posterior portion of the medial condyle was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing and scratching; which are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: revision surgery was performed for reported "poly"wear.X-rays showed varus (with marked thinning of the medial compartment ) and posterior subluxation.The primary knee had significant posterior placement of the femur with notching.Severe wear at the 5 year point in the longevity of the x3 polyethylene is highly unusual.Pcl failure or other cause for knee instability cannot be ruled out as an etiology for revision.A more detailed history and clinicial information may provide better insight into the nature of the knee progression relative to instability.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: an event regarding wear was reported.A material analysis has been performed on the returned device.The report concluded:the damage present on the posterior portion of the medial condyle was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing and scratching; which are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records and x-rays by a clinical consultant indicated: revision surgery was performed for reported "poly"wear.X-rays showed varus (with marked thinning of the medial compartment ) and posterior subluxation.The primary knee had significant posterior placement of the femur with notching.Severe wear at the 5 year point in the longevity of the x3 polyethylene is highly unusual.Pcl failure or other cause for knee instability cannot be ruled out as an etiology for revision.A more detailed history and clinicial information may provide better insight into the nature of the knee progression relative to instability.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
Update: the reason for revision was ¿poly wear.¿.

• Brand Name: X3 TRIATHLON CS INS SIZE4 13MM
• 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: 10179014
• Report Number: 0002249697-2020-01249
• Device Sequence Number: 3082718
• Product Code: MBH
• UDI-Device Identifier: 07613327045819
• UDI-Public: 07613327045819
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 10/31/2019
• Device Model Number: 5531-G-413
• Device Catalogue Number: 5531G413
• Device Lot Number: LEA106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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: 60 YR