MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5532-G-309
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates that devices were manufactured and accepted into final stock no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient underwent manipulation under anaesthesia (mua) of the left knee due to tightness following total knee arthroplasty.
Additional Manufacturer Narrative
An event regarding mua due to arthrofibrosis involving a triathlon insert was reported.The event was confirmed through operative notes received.Method & results: device evaluation and results: no material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: causes of arthrofibrosis are either patient-related or procedure-related.With modern total knee replacement devices, there are no known device related factors that might carry by itself a relationship with poor functional outcome of the knee due to stiffness.Device history review: 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 reported lot.Conclusions: the provided operative notes confirmed the patients arthrofibrosis and the therapeutic intervention to improve rom through mua.The operative notes indicate the mua was performed with success in this patient with ¿audible¿ release of scar tissue and adhesions.The clinician is unable to confirm the root cause for the arthrofibrosis with the supplied information, he states "causes of arthrofibrosis are either patient-related or procedure-related.With modern total knee replacement devices, there are no known device related factors that might carry by itself a relationship with poor functional outcome of the knee due to stiffness".Further information such as patient history and follow-up notes are needed to complete the investigation for determining a root cause.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
Patient underwent manipulation under anaesthesia (mua) of the left knee due to tightness following total knee arthroplasty.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7162351
• Report Number: 0002249697-2018-00043
• Device Sequence Number: 16159039
• Product Code: MBH
• UDI-Device Identifier: 07613327050646
• UDI-Public: 07613327050646
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/01/2018

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-309
• Device Lot Number: DM78WE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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: 59 YR
• Patient Weight: 84