MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ D LM PMA; KNEE PROSTHESIS

Catalog Number	154724
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf anat brg lt lg size 4 pma; item# 159555; lot# 556430.Oxf twin-peg cmntd fem lg pma; item# 161470; lot# 633310.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
It was reported that approximately six years and six months after the initial implantation, the patient underwent a left sided replacement due to pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.Visual examination of the provided picture identified an explanted oxford tibial, femoral and bearing component.The photograph is of poor quality, and nothing further can be gained from the photograph with regards to root cause of the reported event.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified no additional similar complaints for all of the reported oxford components and no additional similar complaints for the reported part and lot combinations.An undated radiograph was provided purported to be taken pre-revision surgery and was reviewed by a radiologist.The review identified a left knee medial compartment hemi arthroplasty without definite radiolucency.There has been an acl repair and no bony fracture or loosening.Overall fit and alignment of the implants is appropriate and there is normal bone quality.There are no anatomic or implant failures seen.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD UNI TIB TRAY SZ D LM PMA
• Common Device Name: KNEE PROSTHESIS
• 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: 19457916
• Report Number: 3002806535-2024-00204
• Device Sequence Number: 6812731
• Product Code: NRA
• UDI-Device Identifier: 05019279388905
• UDI-Public: (01)05019279388905(17)270510(10)294780
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Catalogue Number: 154724
• Device Lot Number: 294780
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG