MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD FIXED LATERAL BRG E5; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Arthritis (1723)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxford fixed lateral brg e5 catalog #: 154230 lot #: 030220, medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 2807475.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00919.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to medial progressive arthritis was performed.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, the oxford fixed lateral bearing item # (b)(4) has been identified as warsaw design control.Accordingly, it was determined an mdr should not have been filed under the current manufacturer.This event will be reported by medwatch facility warsaw biomet (b)(4).

Event Description

Revision due to medial progressive arthritis.

• Brand Name: OXFORD FIXED LATERAL BRG E5
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9457560
• MDR Text Key: 170485326
• Report Number: 3002806535-2019-00918
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 154230
• Device Lot Number: 030220
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104