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

Model Number	5510-F-402
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 referenced.Conclusions: it was reported that the patient was revised due to aseptic loosening of the femoral and tibial components.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Subject had revision of stryker components on (b)(6) 2021 upon enrollment in triathlon cones (76) study.Subject had a patella implanted on (b)(6) 2018 that was not revised.Revision was observed during routine monitoring visit upon review of previous implant information.Pre-op images provided by site to sponsor in intelemage.Update: reason for revision: aseptic failure of the knee -implant migration, loosening of femoral and tibial components.
Event or Problem Description
Subject had revision of stryker components on (b)(6) 2021 upon enrollment in triathlon cones (76) study.Subject had a patella implanted on (b)(6) 2018 that was not revised.Revision was observed during routine monitoring visit upon review of previous implant information.Pre-op images provided by site to sponsor in intelemage.Update: reason for revision: aseptic failure of the knee -implant migration, loosening of femoral and tibial components.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "assessment/conclusions: by report only a revision surgery was performed on a patient who was enrolled in a triathlon cones study.The reason for revision was aseptic failure of the knee with implant migration by report.No medical information, revision data, operative reports, or postoperative images were provided for review.The provided x-rays did not show frank failure.Event confirmation: the revision event cannot be confirmed.Root cause: a root cause cannot be ascertained as the event cannot be confirmed." product history review: review of the device history records indicate 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 referenced.Conclusions: it was reported that the patient was revised due to aseptic loosening of the femoral and tibial components.A review of the provided medical records by a clinical consultant indicated: "assessment/conclusions: by report only a revision surgery was performed on a patient who was enrolled in a triathlon cones study.The reason for revision was aseptic failure of the knee with implant migration by report.No medical information, revision data, operative reports, or postoperative images were provided for review.The provided x-rays did not show frank failure.Event confirmation: the revision event cannot be confirmed.Root cause: a root cause cannot be ascertained as the event cannot be confirmed." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #4 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17151714
• Report Number: 0002249697-2023-00691
• Device Sequence Number: 12267233
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 07/31/2023
• Device Model Number: 5510-F-402
• Device Catalogue Number: 5510F402
• Device Lot Number: D7P4J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White