MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THN 31 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 183440 vngd cr tib brg 10x71/75 lot# 264850; 141205 biomet tibial locking bar lot# 65724514.
Event or Problem Description
It was reported the patient underwent revision for patella disease(pain).To date no additional information or product has been received.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to patella disease(pain near the kneecap) due to progression of arthritis.The patella was resurfacced and the articular surface was exchanged as a best practice.No additional information avaiable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10   disease progression of osteoarthritis can continue in native bone structures as a patient continues to ages.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patient's risk for progressive osteoarthritis.Additionally, females have an inherent risk.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 surgically repair defected area.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SERIES A PAT THN 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18420467
• Report Number: 0001825034-2023-03095
• Device Sequence Number: 12790739
• Product Code: JWH
• UDI-Device Identifier: 00887868344145
• UDI-Public: (01)00887868344145(17)240416(10)593750
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 01/26/2024

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: Health Professional
• Device Expiration Date: 04/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 184784
• Device Lot Number: 593750
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose