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

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 125759509
• Report Number: 0002249697-2018-03414
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050547
• UDI-Public: 07613327050547
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 79