MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL MD; OXFORD CEMENTED FEMORALS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Patient information is not allowed by country regulations.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Fractured femoral component.It was reported that the oxford femoral component broken after 12 years.Revision performed to a tkp.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Implant date received.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial hip arthroplasty on (b)(6) 2009.Subsequently, a revision procedure due to fractured femoral component was performed on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.It was reported that the oxford femoral component broken after 12 years.Revision performed to a tkp.The patient is a runner, running several marathon races with this prosthesis.The oxford femoral component was received in two fragments.The main body of the component fractured across in the medial-lateral direction, slightly towards the anterior side of the component, splitting the component into an anterior and a posterior fragment.An oxford femoral component, implanted as part of the vanguard m partial knee system, has been revised after approximately 12 years due to fracture.The femoral component had fractured into two fragments.Visual examination of the fracture surfaces showed the presence of some faint beach marks, indicating that fatigue may have contributed to the failure.The bone cement mantle also appeared slightly uneven.It is likely that the patient¿s high activity level contributed to the component fracture.Two pre-revision radiographs were received with (b)(4): one anteroposterior (ap) and one mediolateral (ml).The date on which these radiographs were taken has not been provided.Both the ap and the ml radiographs confirm the fracture of the femoral component into at least two large fragments.Third body debris are also observed in the medial, anterior and posterior joint space.It is not clear whether these debris are bone fragments, bone cement fragments, or smaller metal fragments from the fractured femoral component.Immediate post primary radiographs are required to evaluate the initial fit, size and positioning of components.These were requested but were not available.As mentioned in the complaint description, the vanguard m partial knee system was in service for approximately 12 years and the patient is a marathon runner.Other patient details such as age, height, weight, and bmi are not available as they are not allowed by country regulations, as stated in the zimmer biomet product experience report (zper).The manufacturing history records (mhrs) for the oxford femoral component and vanguard m tibial component have been checked and verify that these components were manufactured and sterilised in accordance with the applicable specifications.The instructions for use provided with the oxford femoral component provide the following relevant information: precautions: 2.Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.3.¿excessive activity, trauma and weight gain may contribute to premature failure of implant by loosening, fracture, and/or wear¿ considering the fact that the vanguard m partial knee system was successfully in service for about 12 years in a patient who is a marathon runner, the femoral component performed well.Based on the provided information, the patient¿s intense activity level (marathon running) likely contributed to the reported femoral component fracture.Other contributing factors cannot be discussed without provision of additional radiographs, surgical notes, and without examination of the revised components.Other contributing factors could not be discussed without additional radiographs, surgical notes, examination of the polyethylene bearing/tibial component and patient information.A review of the complaints database shows that we have received 1 reported event for femoral component fracture for the same item number 154601 prior to the reported event.The severity of the reported event for similar complaints are in line with the risk file.The overall score is moderate risk.Capa: no corrective or preventive action required at this time.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.
Event or Problem Description
It was reported that a patient underwent an initial hip arthroplasty on (b)(6) 2009.Subsequently, a revision procedure due to fractured femoral component was performed on (b)(6) 2021.

• Brand Name: OXFORD UNI FEMORAL MD
• Common Device Name: OXFORD CEMENTED FEMORALS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11964240
• Report Number: 3002806535-2021-00244
• Device Sequence Number: 3508398
• Product Code: NRA
• UDI-Device Identifier: 05019279388073
• UDI-Public: 05019279388073
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

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: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 154601
• Device Lot Number: 1692371
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 10/18/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/28/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention