MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5530-G-611
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/02/2019
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Knee revision due to poly wear.
Event or Problem Description
Knee revision due to poly wear.
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed through material analysis of the returned device.Method & results -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 25 september 2019.This inspection indicated.The returned device was examined with the aid of a stereomicroscope at magnifications up to 50x.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, scratching and third body indentations 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.Yellow discoloration, consistent with absorption of synovial fluid, was also observed on the insert.A material analysis has been performed.The report concluded:the damage present on the posterior portion of the medial condyle was consistent with delamination.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: the event description states, ¿knee revision due to poly wear¿.Review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posterior slope.To more accurately determine alignment, full length x-rays would be required.No examination of explanted components and no early post-operative or serial x-rays are available for review.Based upon the information available, no determination can be made regarding the cause of the alleged damage to the x3 polyethylene tibial insert in the right primary total knee arthroplasty in this case.-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.Conclusion: a clinician review of the provided medical records states the following; review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posterior slope.To more accurately determine alignment, full length x-rays would be required.Need serial x-rays and examination of the explanted components.The device was later returned and material analysis was performed which indicated: the damage present on the posterior portion of the medial condyle was consistent with delamination.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8975672
• Report Number: 0002249697-2019-03141
• Device Sequence Number: 10840490
• Product Code: MBH
• UDI-Device Identifier: 07613327050592
• UDI-Public: 07613327050592
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 10/31/2018
• Device Catalogue Number: 5530-G-611
• Device Lot Number: MMP64V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: 67 YR
• Patient Weight: 97