MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	05/11/2010
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 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.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.
Event or Problem Description
This pi was raised from a medical review for pi.The patient underwent surgery on (b)(6)2016 for a periprosthetic fracture of the femur.No components were explanted.
Event or Problem Description
This pi was raised from a medical review for pi.The patient underwent surgery on (b)(6) 2016 for a periprosthetic fracture of the femur.No components were explanted.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned, the reported device remains implanted.Medical records received and evaluation: suboptimal reconstruction of bearing height with the thinnest available 9-mm bearing in a knee joint with major varus deformity and associated bone loss has contributed to early instability in a rather similar way in both knee arthroplasties, implanted during a simultaneous bilateral primary arthroplasty.Multiple additional factors have contributed to a suboptimal end result of the arthroplasty including persistent disease related contracture around the knee requiring early arthroscopic lateral release of the pf-joint in both knees while multiple falling incidents as caused by complex medical comorbidity and required medication have further contributed to the knee laxity by traumatic stretching of knee ligaments.One of the falling incidents caused a periprosthetic fracture just above the left knee arthroplasty requiring open reduction and internal fixation further compromising the functional condition of especially the left knee due to the scar tissue normally associated with fracture healing.Finally did the patient¿s obesity contribute to a secondary but minor degree to the overload condition in the joints, all ultimately requiring bilateral knee revision with bearing exchange within 2-years of primary arthroplasty.Device history review: indicated 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 lot provided.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: suboptimal reconstruction of bearing height with the thinnest available 9-mm bearing in a knee joint with major varus deformity and associated bone loss has contributed to early instability in a rather similar way in both knee arthroplasties, implanted during a simultaneous bilateral primary arthroplasty.Multiple additional factors have contributed to a suboptimal end result of the arthroplasty including persistent disease related contracture around the knee requiring early arthroscopic lateral release of the pf-joint in both knees while multiple falling incidents as caused by complex medical comorbidity and required medication have further contributed to the knee laxity by traumatic stretching of knee ligaments.One of the falling incidents caused a periprosthetic fracture just above the left knee arthroplasty requiring open reduction and internal fixation further compromising the functional condition of especially the left knee due to the scar tissue normally associated with fracture healing.Finally did the patient¿s obesity contribute to a secondary but minor degree to the overload condition in the joints, all ultimately requiring bilateral knee revision with bearing exchange within 2-years of primary arthroplasty.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9285957
• Report Number: 0002249697-2019-03711
• Device Sequence Number: 2310899
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• 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: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 09/30/2014
• Device Catalogue Number: 5510F502
• Device Lot Number: SNXSX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: 62 YR