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-319
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2018
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 events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Knee revision was performed due to instability.
Additional Manufacturer Narrative
An event regarding revision due to instability with malposition of the baseplate 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: 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.Delamination burnishing, scratching and third-body indentations being observed on the insert.Delamination, 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: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing.- 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: 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.Delamination burnishing, scratching and third-body indentations being observed on the insert.Delamination, 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 and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing.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
Knee revision was performed due to instability update based on medical review: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal have rendered the pcl dysfunctional with severe instability.

• 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: 7597020
• Report Number: 0002249697-2018-01797
• Device Sequence Number: 19129359
• Product Code: MBH
• UDI-Device Identifier: 07613327050493
• UDI-Public: 07613327050493
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 5530-G-319
• Device Lot Number: M88MLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 68 YR
• Patient Weight: 39