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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.The revision is due to a fall but with the available information, a definitive root cause could not be determined.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.

• Brand Name: OXFORD ANAT BRG RT SM SIZE 6 PMA
• Common Device Name: 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
• Report Number: 3002806535-2024-00120
• Device Sequence Number: 11767511
• Product Code: NRA
• UDI-Device Identifier: 05019279786176
• UDI-Public: (01)05019279786176(17)200303(10)3527153
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 06/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/23/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose