MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will be 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

A revision procedure was reported due to a fractured oxford bearing.

Event Description

A revision procedure was reported due to a fractured oxford bearing.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: product item no.: 159548.Product lot no.: 1639448.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: it was reported that: uka was performed with oxford on (b)(6) 2018.Postoperatively, the patient who underwent the initial operation felt a pain to see a doctor.At the diagnosis, tibial tray sinking was confirmed.A revision was performed to replace the tibial tray, bearing and femoral component on (b)(6) 2021.At the revision, the surgeon confirmed wear on the explanted bearing.Patient involved addi (b)(6) 2021: 1.Was the cause of the tibial tray sinking due to bone degeneration? yes.5.Name of the surgeon who performed the initial procedure? dr.(b)(6).Implant examination.The revised oxford meniscal bearing was received in two fragments.The fracture of the bearing is located slightly more towards the posterior portion of the bearing, and splits the bearing in to anterior and posterior fragments.The superior articulating surface appears polished.The inferior articulating surface shows scratches mostly in the direction of articulation.Extensive wear is observed on both superior and inferior articulating surfaces at the fracture interface next to the lateral edge of the bearing.Yellowing, oxidation and delamination of the bearing is also observed, mostly in the region of the above-mentioned extensive wear.The meniscal bearing received with (b)(4) was measured with a digital calliper and compared to the nominal dimensions in the relevant engineering drawing.The thickness of the posterior aspect and anterior aspect were measured at the thinnest point and were found to have reduced below the allowed tolerances defined in the engineering drawing.The thickness of the central region of the bearing was measured from the thinnest point on the anterior fragment of the bearing and was also found to have reduced below the defined tolerances.An oxford meniscal bearing was revised due to fracture after approximately 12 years in use.The manufacturing history records (mhrs) for the received bearing have been checked and verify that the part was manufactured and sterilised in accordance with the applicable specifications.The component was received fractured in two fragments.Visual analysis shows extensive wear of the bearing in the fracture region next to the lateral edge.The measurements taken on the bearing indicated a worst-case wear rate of approximately 0.125 mm/year.Based on the available information, it is possible that unusual stress conditions and oxidation may have led to the subsequent reduction in service life of the component.Other contributing factors cannot be discussed without provision of radiographic information, additional patient information and surgical notes.A review of the complaints database shows that we have received one reported event for revision due to implant fracture for the same item number prior to the reported event.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to reported event.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: oxford bearing fractured, originally implanted in 2009.Patient involvement.

• Brand Name: OXF ANAT BRG LT MD SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12539050
• MDR Text Key: 273530597
• Report Number: 3002806535-2021-00406
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 1639448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female