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

Catalog Number	5530-G-211
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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
It was reported that the patient's right knee was revised due to subluxation.The posterior portion of the poly fractured off, which caused the subluxation.The piece of the poly was in the joint space and damaged the patellar component.Surgeon revised patellar component and cr poly was revised to a cs 2x13 poly.Rep reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right knee was revised due to subluxation.The posterior portion of the poly fractured off, which caused the subluxation.The piece of the poly was in the joint space and damaged the patellar component.Surgeon revised patellar component and cr poly was revised to a cs 2x13 poly.Rep reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert leading to subluxation was reported.The event of crack/fracture was confirmed by material analysis of the returned device.Subluxation/instability was not confirmed.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 06 may 2019 which indicated: damage was observed on the insert, consistent with contact against the femoral components.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was observed on the anterior surface of the insert.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.The posterior end of the lateral and medial articulating condyle surfaces had delamination and material loss observed, consistent with the insert loaded from the posterior side.A review of the returned product by a material analysis engineer revealed: burnishing, scratching and third-body indentations were observed on the tibial insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had delamination and material loss consistent with the insert loaded from the posterior side.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Burnishing and scratching, delamination and material loss were observed on the patella insert.The anterior surface of the patella insert was damaged to explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: not performed as no medical records were received for review with a clinical consultant.Product 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: a review of the returned product by a material analysis engineer revealed: burnishing, scratching and third-body indentations were observed on the tibial insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had delamination and material loss consistent with the insert loaded from the posterior side.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Burnishing and scratching, delamination and material loss were observed on the patella insert.The anterior surface of the patella insert was damaged to explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Further information such as pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.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, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8522735
• Report Number: 0002249697-2019-01644
• Device Sequence Number: 19307825
• Product Code: MBH
• UDI-Device Identifier: 07613327045444
• UDI-Public: 07613327045444
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 11/30/2013
• Device Catalogue Number: 5530-G-211
• Device Lot Number: LBG804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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