MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT MD SIZE 4 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery on the left knee approximately one year post implantation, due to pain and instability.Only the oxford bearing was revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 ¿ item# 166574, oxf uni cmntls tib sz c lm, lot# 7172836.Item#, 154926 oxford ph3 cementless fem sz m, lot# 7206961.G2 ¿ foreign ¿ australia.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.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 that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.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 LT MD SIZE 4 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: 19151495
• Report Number: 3002806535-2024-00153
• Device Sequence Number: 8464552
• Product Code: NRA
• UDI-Device Identifier: 05019279785940
• UDI-Public: (01)05019279785940(17)250807(10)6839877
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 6839877
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 106 KG