MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5517F501

Device Problems Unstable (1667); Malposition of Device (2616); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to instability involving a triathlon femoral component was reported.The event was confirmed based on the clinician review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary: arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.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: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.X-rays and return of the device are needed to further investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not available.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "left knee, failed total knee arthroplasty." update to event description based on clinician review of the medical records provided: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: margaret foley ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 9151364
• MDR Text Key: 162473726
• Report Number: 0002249697-2019-03366
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 5517F501
• Device Lot Number: EB6SF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR