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	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
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 clinician review of the medical records provided.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 29 march 2019.This inspection indicated "the articulating, distal, anterior and posterior surfaces of the insert.The part was examined with the aid of a stereo microscope at magnifications up to 50x.Damage was observed on the articulating condyles of the insert consistent with contact against the femoral condyles.Debris was also observed on the insert.A sample of the debris was placed on a scanning electron microscope (sem) stub for further analysis.Damage consistent with the explantation process was also observed on the insert.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Delamination, burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid." dimensional 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.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: "damage was observed on the articulating condyles of the insert consistent with contact against the femoral condyles.Debris was also observed on the insert.Damage consistent with the explantation process was also observed on the insert.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Delamination, burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Eds showed the debris was consistent with an oxide formation and ca-p is consistent with biological material or fixation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: "x-ray printouts available for review include a series dated on (b)(6) 2007, which is an ap, lateral and patellar view of the right knee demonstrating tricompartmental osteoarthritis primarily involving the medial and patellofemoral compartments.X-rays dated on (b)(6) 2007 are two aps and two laterals of the right knee demonstrating an uncemented right total knee arthroplasty with no patellar resurfacing.Skin staples are in situ and the components appear in nominal position.X-rays dated on (b)(6) 2018 are an ap, lateral and patellar view of the right knee, which is unchanged from the previous film, however some patellofemoral osteoarthritis is noted at this time.There is no examination of the explanted poly insert and no description of symptoms leading to the revision surgery of on (b)(6) 2019 available.If pain and effusion were present, it could have resulted from the increased patellofemoral arthritis of the unresurfaced patella.¿partial delamination¿ of the posterior poly insert is not unexpected after twelve years of active use.There is no evidence that factors of faulty component design, manufacturing or materials as being responsible for this clinical event." device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the medical review concluded "¿partial delamination¿ of the posterior poly insert is not unexpected after twelve years of active use.There is no evidence that factors of faulty component design, manufacturing or materials as being responsible for this clinical event and the mar further stated."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.
Event or Problem Description
Knee revision due to poly wear.

• 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: 8358488
• Report Number: 0002249697-2019-01126
• Device Sequence Number: 2137873
• 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: 2007
• 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): 05/29/2019

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: 06/30/2011
• Device Catalogue Number: 5530-G-611
• Device Lot Number: 2K2MKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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: 62 YR
• Patient Weight: 78