MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5532-G-709
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348)
Date of Event	11/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Doctor reported patient presented to emergency department on (b)(6) (approximately 6 months post triathlon ps total knee replacement) with a locked knee post reported hyperflexion (patient crouching to tie his contralateral shoe lace).Findings on x-ray revealed a malplaced femoral component over the insert post of the tibial insert.The patient's knee was relocated under anaesthetic on (b)(6).
Additional Manufacturer Narrative
An event regarding dislocation involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-medical records received and evaluation: retention of extensive calcifications in the posterior knee joint space during primary arthroplasty has caused limitation of knee flexion in the triathlon ps arthroplasty.Forced hyperflexion of the knee during the adverse event caused the incompressible calcifications to lift the femoral component over the tibial post in anterior direction causing a locked knee requiring.-device history review: indicated that devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusion: clinician review of this case indicated: principal problem is caused by the retention of the calcifications in the posterior knee joint space during arthroplasty which is a procedure-related failure mode because the surgeon is responsible for optimal surgical technique which should include adequate removal of osteophytes and other abnormal calcifications in and around the knee joint during arthroplasty.It is well recognized that retention of abnormal calcifications in the posterior knee joint space causes limitation in knee flexion and if then flexion is forced, an overload condition develops where phenomena such as the observed dislocation may occur due to abnormal leverage forces of the femur relative to the tibia.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Doctor reported patient presented to emergency department on (b)(6) (approximately 6 months post triathlon ps total knee replacement) with a locked knee post reported hyperflexion (patient crouching to tie his contralateral shoe lace).Findings on x-ray revealed a malplaced femoral component over the insert post of the tibial insert.The patient's knee was relocated under anaesthetic on (b)(6).

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7104468
• Report Number: 0002249697-2017-03536
• Device Sequence Number: 10957960
• Product Code: MBH
• UDI-Device Identifier: 07613327046274
• UDI-Public: 07613327046274
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 10/06/2020
• Device Catalogue Number: 5532-G-709
• Device Lot Number: LEP894
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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: 65 YR
• Patient Weight: 78