MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	5532-G-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that 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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of total knee arthroplasty for instability.
Additional Manufacturer Narrative
An event regarding revision due to instability involving a triathlon insert was reported.The event was confirmed through medical review of provided documentation.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: instability due to an adverse mix of patient-related factors (ligament pathology either present prior to arthroplasty or acquired after arthroplasty) plus procedure-related factors as caused by mismatch in component size relative to the ligament constraints of the knee as determined by the native anatomy.Device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: revision surgery took place due to instability whereby the reported insert was revised.Review of the medical documentation provided indicates: instability due to an adverse mix of patient-related factors (ligament pathology either present prior to arthroplasty or acquired after arthroplasty) plus procedure-related factors as caused by mismatch in component size relative to the ligament constraints of the knee as determined by the native anatomy.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
Revision of total knee arthroplasty for instability.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7191425
• Report Number: 0002249697-2018-00152
• Device Sequence Number: 16381010
• Product Code: JWH
• UDI-Device Identifier: 07613327050721
• UDI-Public: 07613327050721
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 05/13/2021
• Device Catalogue Number: 5532-G-413
• Device Lot Number: 6M0497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 03/02/2018
• 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: 64 YR
• Patient Weight: 57