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-309
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/17/2018
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 reported lot.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.
Event or Problem Description
Revision surgery.Sales rep advised over the phone that the reason for revision was a fracture in the original implant, which caused pain.
Event or Problem Description
Revision surgery.Sales rep advised over the phone that the reason for revision was a fracture in the original implant, which caused pain.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed through return of the fractured device.The posterior tip of one of the compartments of the insert component is fractured off.Material analysis carried out on the returned device concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had fractured due to an overload condition.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.The source of the debris observed on the insert could not be determined.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: review of the provided medical records by a clinician indicated: inadequate bearing thickness during primary arthroplasty has contributed to early instability requiring revision to a thicker bearing.Inadequate bearing thickness during primary arthroplasty.Possible dysfunctional pcl due to degenerative knee disease or past trauma.No device-related factors are associated with any of the implanted devices consistent with the type of failure.Indicates all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.Device evaluation confirmed that the posterior tip of one of the compartments of the insert component is fractured off.Material analysis carried out on the returned device concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had fractured due to an overload condition.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.The source of the debris observed on the insert could not be determined.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Review of the provided medical records by a clinician indicated: inadequate bearing thickness during primary arthroplasty has contributed to early instability requiring revision to a thicker bearing with possible dysfunctional pcl due to degenerative knee disease or past trauma.No device-related factors are associated with any of the implanted devices consistent with the type of failure.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: 7876771
• Report Number: 0002249697-2018-02878
• Device Sequence Number: 11277945
• Product Code: MBH
• UDI-Device Identifier: 07613327050431
• UDI-Public: 07613327050431
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 5530-G-309
• Device Lot Number: 215X6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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: 55 YR
• Patient Weight: 87