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 Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's right knee was revised due to range of motion issues.A cr femur and cs insert were revised to a ps femur with ts insert.Rep confirmed that there were no allegations against the revised insert.
Additional Manufacturer Narrative
An event regarding arthrofibrosis involving a triathlon femoral component was reported.The event was confirmed via clinician review of the provided medical records.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: "a patient underwent a tka, no preoperative data or x-rays were provided for review.No data on the procedure was provided but an implant sheet noted a cemented knee cr with cs polyethylene.A verasense device was apparently used and was noted as not implanted and broken.The postoperative records were not provided for review.No radiographs were provided for review.The patient had a poor outcome with stiffness, a flexion contracture and poor flexion, and hypertrophic scarring.The patient was offered revision with proposal to convert to a ps style knee and resect scar.No records outside the implant sheet were provided for the procedure.No radiographs were provided.The femoral component was revised to a ps style femur and a ts polyethylene was used.No postoperative data was provided for review.Event confirmation: a primary cr knee with cs poly and revision to a ps knee with ts polyethylene can be confirmed.The verasense device appears to have been opened and was noted as broken but this cannot be confirmed.Root cause: the root cause of the revision was ¿arthrofibrosis¿ with a flexion contracture and poor flexion.The root cause of the verasense issue and breakage cannot be determined or 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 range of motion issues.A review of the provided medical records by a clinical consultant indicated: "a patient underwent a tka, no preoperative data or x-rays were provided for review.No data on the procedure was provided but an implant sheet noted a cemented knee cr with cs polyethylene.A verasense device was apparently used and was noted as not implanted and broken.The postoperative records were not provided for review.No radiographs were provided for review.The patient had a poor outcome with stiffness, a flexion contracture and poor flexion, and hypertrophic scarring.The patient was offered revision with proposal to convert to a ps style knee and resect scar.No records outside the implant sheet were provided for the procedure.No radiographs were provided.The femoral component was revised to a ps style femur and a ts polyethylene was used.No postoperative data was provided for review.Event confirmation: a primary cr knee with cs poly and revision to a ps knee with ts polyethylene can be confirmed.The verasense device appears to have been opened and was noted as broken but this cannot be confirmed.Root cause: the root cause of the revision was ¿arthrofibrosis¿ with a flexion contracture and poor flexion.The root cause of the verasense issue and breakage cannot be determined or confirmed." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to range of motion issues.A cr femur and cs insert were revised to a ps femur with ts insert.Rep confirmed that there were no allegations against the revised insert.

• 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
• 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: 18823369
• Report Number: 0002249697-2024-00330
• Device Sequence Number: 17927196
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 Catalogue Number: 5510F502
• Device Lot Number: RYH3Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/02/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 118 KG