MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT SM SIZE 6 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial right knee arthroplasty approximately six years ago.Subsequently, a revision procedure was performed due to a fall leading to knee instability, was performed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 ¿ oxf uni cmntls tib sz c rm, item# 166575, lot# 6005869.Oxford ph3 cementless fem sz s, item# 154925, lot# 6195794.G2 ¿ foreign ¿ new zealand.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00119.3002806535 - 2024 - 00121.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h11.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXFORD ANAT BRG RT SM SIZE 6 PMA
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 19017895
• MDR Text Key: 339082405
• Report Number: 3002806535-2024-00120
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786176
• UDI-Public: (01)05019279786176(17)200303(10)3527153
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 159571
• Device Lot Number: 3527153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose