MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-301
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	10/03/2018
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.
Event or Problem Description
Postoperative diagnosis: the patient underwent left total knee replacement (b)(6) 2018.Left knee reveals subsided femoral implant into varus.Patient underwent left total knee revision with distal femoral replacement for periprosthetic left femur fracture (b)(6) 2018.
Event or Problem Description
Postoperative diagnosis: the patient underwent left total knee replacement (b)(6) 2018.Left knee reveals subsided femoral implant into varus.Patient underwent left total knee revision with distal femoral replacement for periprosthetic left femur fracture (b)(6) 2018.
Additional Manufacturer Narrative
An event regarding a periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed through clinician review of the provided x-rays.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms periprosthetic fracture, need additional information; primary and revision operative reports, clinical and past medical history.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: while the event was confirmed through clinical review of the provided x-ray, the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history 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 FEM COMPONENT, CEMENTED
• 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: 8569654
• Report Number: 0002249697-2019-01815
• Device Sequence Number: 13905708
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 07/31/2022
• Device Catalogue Number: 5515-F-301
• Device Lot Number: ALH7OD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 89 YR
• Patient Weight: 67