MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE 12MM HEIGHT SIZE D ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: rotating hinge knee left size d cemented option catalog#: 00588001401 lot#: 65590247.Size 3 precoat non-modular cemented tibial component catalog#: 00588000302 lot#: 66081854.12mm diameter 100mm length offset stem extension combined length 145mm catalog#: 00598802012 lot#: 64323106.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately fifty days post-implantation due to stiffness.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Visual evaluation of pictures provided identified that the explanted devices were covered in bio-debris.No further evaluation could be made based on the picture provided.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROTATING HINGE KNEE 12MM HEIGHT SIZE D ARTICULAR SURFACE
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19688911
• Report Number: 0001822565-2024-02254
• Device Sequence Number: 15233263
• Product Code: JWH
• UDI-Device Identifier: 00889024199309
• UDI-Public: (01)00889024199309(17)280920(10)66188481
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/13/2024

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 Model Number: N/A
• Device Catalogue Number: 00588004012
• Device Lot Number: 66188481
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female