MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS

Catalog Number 159547

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- oxf twin peg cmntls fmrl md , item 161474, lot r2503468a, therapy date - device remains implanted, oxford cementless tibia d lm , item us166576, lot r3050478a, therapy date - device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01197 and 3002806535-2018-01199.

Event Description

It has been reported by the clinical study group that the patient underwent an initial left knee arthroplasty.Subsequently, during a follow-up visit it was reported that the x-ray showed a radiolucent line under the tibial tray.The adverse event report stated that the severity was mild.No treatment was given.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided: there is a thin radiolucent line present beneath the tibial tray.The oxford surgical technique states: 'histologically, the radiolucent line represents a layer of fibrocartilage, with its collagen organized parallel with the plateau.The radiodense line represents a new ¿subchondral bone plate.¿ the trabeculae, which were cut at the operation, attach to this plate and support it.The collagen fibers of the cartilage layer insert into its upper surface.There are some areas within the radiolucency in which there is direct contact between cement and bone.¿the radiographic changes which occur during the first postoperative year result from healing of the cut bone and its remodeling to sustain the new pattern of compressive load applied to it by the rigid implant.A review of oxford partial knee patients found no relationship between the presence of radiolucent lines and clinical outcomes.[gulati et al 2009]' the manufacturing history records (mhrs) for the oxford partial knee femoral, tibial and bearing components have been checked and verify that the components were manufactured and sterilised correctly.There is no indication that the reported adverse event is related to the function of the device.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported by the clinical study group that the patient underwent an initial left knee arthroplasty.Subsequently, during a follow-up visit it was reported that the x-ray showed a radiolucent line under the tibial tray.The adverse event report stated that the severity was mild.No treatment was given.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8072980
• MDR Text Key: 127206757
• Report Number: 3002806535-2018-01198
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 159547
• Device Lot Number: 154680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 88