MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5510F401
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/18/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar event 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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
Medical review identified 2 additional revision surgeries for instability for this patient.This pi is for the second revision surgery which took place on (b)(6) 2014.It was reported through the communication of an attorney that allegedly the patient was revised due to "instability of left total knee arthroplasty." medical review stated: early postoperative the knee did reasonably well but patient returned already on (b)(6) 2013, with persistent pain and popping sensations in the left knee.Upon physical examination diffuse instability was noted, both in varus/valgus as well as anterior/posterior, both in extension and flexion with hyperextension being present in the knee.A diagnosis of instability was made with an assumption that the pcl (posterior cruciate ligament) was damaged, something that explains instability with a cr type knee that requires an intact pcl.Conversion to a posterior stabilised (ps) knee was deemed necessary requiring femoral exchange because of the box for the post/cam mechanism.This second left knee revision was performed on (b)(6) 2014, with exchange of the triathlon cr for a triathlon ts with ps bearing insert.Tibia was retained.Posterior and distal augments were required with bone graft and a 100-mm fluted stem extender on the femur.Postoperative rehabilitation was uneventful for the first few years.There was occasional pain while ¿subtle instability¿ was noted in the records without further specification.

• Brand Name: TRIATHLON CR FEM COMP #4 L-CEM
• 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: 8959755
• Report Number: 0002249697-2019-03073
• Device Sequence Number: 19450508
• Product Code: MBH
• UDI-Device Identifier: 07613327040272
• UDI-Public: 07613327040272
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 03/31/2014
• Device Catalogue Number: 5510F401
• Device Lot Number: SL38X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/04/2019
• 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