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-411

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/16/2018

Event Type  Injury  

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 events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Patient needed knee revision.The reason is ¿instability¿ in the knee.

Manufacturer Narrative

Product available to stryker; returned to manufacturer on.An event regarding revision due to instability involving a triathlon insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: device evaluation and results:material analysis report (mar) indicated: the part was examined with the aid of a stereo microscope at magnifications up to 50x.Damage consistent with the explantation process and contact against the femoral component were observed on the insert.Impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Explantation damage and markings consistent with contact against the baseplate were also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: the medical review indicated: baseplate malposition in excessive posterior tibial slope with choice for cr type of components in a knee with long standing stability problems has contributed to early failure of the triathlon cr arthroplasty with recurrent instability requiring exchange to triathlon ts.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 mar indicated that the part was examined with the aid of a stereo microscope at magnifications up to 50x.Damage consistent with the explantation process and contact against the femoral component were observed on the insert.Impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Explantation damage and markings consistent with contact against the baseplate were also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The medical review indicated that baseplate malposition in excessive posterior tibial slope with choice for cr type of components in a knee with long standing stability problems has contributed to early failure of the triathlon cr arthroplasty with recurrent instability requiring exchange to triathlon ts.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

Patient needed knee revision.The reason is ¿instability¿ in the knee.

• 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: 7537882
• MDR Text Key: 109044750
• Report Number: 0002249697-2018-01553
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 5530-G-411
• Device Lot Number: JJ0MKM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 66