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-611
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar 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 to the manufacturer.
Event or Problem Description
Patient lost range of motion and underwent revision of liner from an 11mm to a 9mm.All other components were retained on (b)(6) 2018".
Event or Problem Description
Patient lost range of motion and underwent revision of liner from an 11mm to a 9mm.All other components were retained on (b)(6) 2018".
Additional Manufacturer Narrative
An event regarding range of motion issues involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: on (b)(6) 2018, a right total knee arthroplasty revision (changed liner and scar excision) was performed for a diagnosis of right knee arthrofibrosis.The operative report describes a tourniquet time of forty-one minutes.The operative report notes, ¿complains of pain and stiffness after neurectomy, no evidence of infection complete synovectomy and tenolysis to free up extensor mechanism liner removed noted to be in good condition changed to a 9mm ps insert 0° to 115° good stability.¿ uncomplicated surgery was described.X-ray printouts available for review include a series dated on (b)(6) 2018, which is an ap of the right knee, a patellar view of both knees and a lateral of the right knee, demonstrating a right total knee arthroplasty with an uncemented tibial and patellar component, a modular long-stem revision femoral component with hybrid cementation, and a distal cone augment.Nominal position of all components is noted.No primary right total knee operative report, no x-rays or bone scan images to confirm loose primary femoral component, and no examination of the explanted primary femoral component is available.No clinical or past medical history regarding either conditions or medications that may discouraged biologic fixation of the femoral component or radiographic evidence of good primary prosthesis/bone contact are available.Based upon the information available for review, no determination can be made regarding the cause of the alleged failure of bony fixation of the uncemented femoral component fifteen months post implantation in this case.The subsequent surgery for arthrofibrosis was not related to factors of implant design, manufacturing or materials and is a common complication of total knee arthroplasty surgery.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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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: 7969504
• Report Number: 0002249697-2018-03371
• Device Sequence Number: 1739054
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 09/30/2020
• Device Catalogue Number: 5532-G-611
• Device Lot Number: NV4RRX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 03/14/2019
• 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: 99