MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.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 Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due to bearing fracture was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: product information received: lot number: 2649540.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2013.Subsequently, a revision procedure due to bearing fracture was performed on (b)(6), 2021.

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 a patient underwent an initial knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due to bearing fracture was performed on (b)(6) , 2021.Patient has operated (b)(6) 2013 using oxford.Bearing thickness was 3mm.Now after several years patient has suddenly felt pain after being kneeling and x-ray showed that the bearing is broken and need to be changed.The surgeon said that he has already had more than one cases where the bearing has cracked.He is wondering it 3mm bearing should use at all.Implant examination: the polyethylene bearing was received in two fragments.The fracture of the bearing is observed approximately across the middle of the component.The superior articulating surface appears polished, which is at an angle relative to the longitudinal axis of the bearing and where scratches and pitting are observed.Extensive wear and damage is observed to the inferior articulating surface of the bearing, particularly in the postero-medial portion of the bearing.It is possible that the fracture initiated from this postero-medial region.Yellowing and oxidation of the material can also be observed.Wear and thinning of the material, which was reported by the surgeon during revision as stated in the complaint description.Implant measurement: the meniscal bearing received with (b)(4) was measured with a digital caliper and compared to the nominal dimensions in the relevant engineering drawing.Dimensional changes show significant wear of the bearing.The thickness of the posterior aspect was measured at the thinnest point and it was found to have reduced below the allowed tolerances defined in the engineering drawing.The anterior aspect and central region of the bearing were also found to have reduced below the defined tolerances.However, above measured dimensions may have been affected by autoclaving.A left oxford anatomic bearing was revised due to fracture after approximately 7 years and 5 months in use.The component was received fractured in two fragments.Visual and radiographic analysis suggests that the bearing may have been articulating against the medial edge of the tibial tray, which is consistent with the extensive wear observed on its inferior surface, especially in the postero-medial region.The thickness of the central region was found to have reduced during service by 0.58 mm below its nominal thickness, indicating a wear rate of approximately 0.08 mm/year.Based on the available information, it is possible that suboptimal sizing, positioning and alignment of components, as well as the patient¿s body weight, may have resulted in unusual stress conditions that may have led to the subsequent reduction in service life of the component.Other contributing factors cannot be discussed without provision of additional patient information and surgical notes.The bearing was manufactured and sterilised in accordance with the applicable specifications.A review of the complaints database shows that we have received 1 reported event for bearing fracture for the same item number 159547 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 Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due to bearing fracture was performed on (b)(6), 2021.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11982311
• MDR Text Key: 255606413
• Report Number: 3002806535-2021-00256
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2649540
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention