MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5531G416
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/04/2019
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
Dr.Informed me of a stryker knee revision where he requested a poly exchange.During surgery he discovered that the poly was worn posteriorly.He was unsatisfied with stability after a trial so extracted the femoral component.
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated on (b)(6) 2019.This inspection indicated.The device was assumed to be from a right knee if information arises that states the opposite the medial and lateral designation will switch.The device was examined with the aid of a stereo microscope at magnifications up to 50x.Damage on the articulating surface of the insert is consistent with contact against the femoral component.Material loss was observed on the medial and lateral condyles.Backside impressions on the distal side of the insert are consistent surface is consistent with delamination, burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Damage consistent with explantation was observed on the anterior surface of the insert.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the devices.Dimensional & functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: a material analysis has been performed.The report concluded:the insert was observed to have explantation damage and material loss.The tibial insert was observed to have burnishing, scratching, third body indentations, and delamination;these are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the insert.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.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 operative reports and progress notes are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Dr.Informed me of a stryker knee revision where he requested a poly exchange.During surgery he discovered that the poly was worn posteriorly.He was unsatisfied with stability after a trial so extracted the femoral component.

• Brand Name: X3 TRIATHLON CS INS SIZE4 16MM
• 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: 8748315
• Report Number: 0002249697-2019-02432
• Device Sequence Number: 1708108
• Product Code: MBH
• UDI-Device Identifier: 07613327045833
• UDI-Public: 07613327045833
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 09/30/2014
• Device Catalogue Number: 5531G416
• Device Lot Number: LBQ608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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: 59 YR