MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: rotating hinge knee 12mm height size e articular surface catalog#: 00588005012 lot#: 66141954 12mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801012 lot#: 65813042 trabecular metal femoral diaphyseal cone, 30mm, small, left catalog#: 00545001730 lot#: 66004342 unknown tibial tray catalog#: ni lot#: ni.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 five months post-implantation due to stiffness.The femoral and insert were removed and replaced.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, h10, and h11.Proposed component code: mechanical (g04) - femur.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: ROTATING HINGE KNEE LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT
• 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: 20465761
• Report Number: 0001822565-2024-03291
• Device Sequence Number: 12630377
• Product Code: JWH
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)281017(10)6577768
• 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): 01/02/2025

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: 00588001501
• Device Lot Number: 65777768
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male