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-511
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Upon insertion of triathlon cr 5x11 insert, the plastic would not seat fully.Numerous attempts were made.Surgeon noted that wire was exposed but that insert seemed fully seated.A new insert was opened and implanted successfully.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed through review of the returned device.Damage observed on the insert consistent with attempted implantation and explantation.Damage was also observed on the insert consistent with contact against a hard object.Asymmetrical damage was observed on the posterior end of the distal surface of the insert.Scratching was observed on the insert condyles.This is a common damage mode of uhmwpe.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 provided for review.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The insert was returned for review- damage observed on the insert consistent with attempted implantation and explantation.Damage was also observed on the insert consistent with contact against a hard object.Asymmetrical damage was observed on the posterior end of the distal surface of the insert.Scratching was observed on the insert condyles.This is a common damage mode of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.While it can be confirmed that a setting issue did take place through return of the component, the root cause cannot be determined as insufficient information was provided.Further information such as operative reports/images of the device taken when the alleged event was identified is required to complete the investigation.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
Upon insertion of triathlon cr 5x11 insert, the plastic would not seat fully.Numerous attempts were made.Surgeon noted that wire was exposed but that insert seemed fully seated.A new insert was opened and implanted successfully.

• 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: 7975554
• Report Number: 0002249697-2018-03414
• Device Sequence Number: 201527
• Product Code: MBH
• UDI-Device Identifier: 07613327050547
• UDI-Public: 07613327050547
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 5530-G-511
• Device Lot Number: PN6KA0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 79