MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 4 PMA; KNEE PROSTHESIS

Catalog Number	159576
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Insufficient Information (4580)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent initial right unicompartmental knee arthroplasty.Subsequently, the patient was revised approximately 10 years and 4 months post the initial implantation due to progression of osteoarthritis of native patella.The poly was exchanged with patella implanted without complications.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 information.The following sections were updated: a1, a2, b4, b5, d6, d10, g3, g6, h2, h6, h11.D10 - associated medical products: oxford cementless tibia d rm; item# us166577; lot# 3050480.Oxf twin peg cmntls fmrl md; item# 161474; lot# 2494942.Disease progression of osteoarthritis can continue in native bone structures as a patient continues to age.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patient¿s risk for progressive osteoarthritis.Additionally, females have an inherent risk.Partial knee replacement is done to decrease pain, and increase flexibility, mobility and overall improve quality of life, as this is one of the least invasive approaches.Patients with disease progression of osteoarthritis in the affected joint develop knee pain and decrease in joint flexibility.As osteoarthritis progresses a loss of cartilage in the previously unaffected area of the knee has deteriorated to a point in which the patient and doctor may elect to take an approach to convert to a full-knee replacement to alleviate symptoms.As the zimmer biomet device did not cause this event or is meant to cure and/or prevent progression of pre-existing patient diseases, no further reports will be submitted in regard to this case.However, if any additional 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.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: unknown oxford tibial component; item# unknown; lot# unknown unknown oxford femoral component; item# unknown; lot# unknown 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 the patient underwent a right sided knee revision on an unknown date due to instability.It was noted that just the poly was revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 4 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: 19592606
• Report Number: 3002806535-2024-00231
• Device Sequence Number: 8470770
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: (01)05019279786220(17)181231(10)331510
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 08/06/2024

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: 12/31/2018
• Device Catalogue Number: 159576
• Device Lot Number: 331510
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2013
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 90 KG