MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).Surgeon didn't approve for return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported by the hospital that a patient underwent initial partial knee arthroplasty.Subsequently, the patient was revised due to bearing wear.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Post-primary radiographs have not been received and therefore the initial component sizing, positioning and alignment cannot be assessed.The mediolateral radiograph shows the presence of debris in the posterior joint space, most likely a fragment of bone or bone cement.The position of the two x-ray marker wires of the polyethylene bearing, one anterior to the femoral component and one behind the posterior portion of the femoral component, indicate that the bearing had fractured.It is not possible to determine when this occurred with the information available at the time of writing this assessment.The anteroposterior radiograph shows bone medially to the tibial tray, which may indicate subsidence of the component.The cement mantle below the tibial tray appears uneven and bone resorption is visible laterally to and below the vertical wall of the tibial tray.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported by the hospital that a patient underwent initial partial knee arthroplasty.Subsequently, the patient was revised due to bearing wear.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8779782
• MDR Text Key: 150676235
• Report Number: 3002806535-2019-00604
• 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
• Report Date: 12/10/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/10/2019
• 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