MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE 17MM HEIGHT SIZE D ART. SURFACE; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3 event date: unknown date in october 2022.D6b explant date: unknown date in (b)(6) 2022.D10 therapy date: unknown date in (b)(6) 2022.D10 medical devices: 13mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801013 lot#: 65027757.Palacos r + g (1x40) catalog#: 66022663, lot#: 98091024.Unknown tibial tray catalog#: ni lot#: ni.Left size d cemented option femoral component catalog#: 00588001401 lot#: 64549912.Trabecular metal femoral diaphyseal cone, 30mm, medium, left catalog#: 00545001830 lot#: 63770738.Femoral augment block distal only precoat size d 20 mm augment with screw catalog#: 00599003424 lot#: 64103993.Femoral augment block distal only precoat size d 20 mm augment with screw catalog#: 00599003424 lot#: 77003570.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 rotating hinge knee procedure.In the same month, the patient required a knee reconstruction with a right gastrocnemius flap.Subsequently, approximately seven months post implantation, the patient underwent a poly exchange for unknown reason, along with vastus lateralis free flap, followed by an extensor tendon reconstruction, and finally a washout post free flap reconstruction.No further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11 reported event was confirmed by review of operative notes provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Operative notes review indicates that the patient underwent a poly exchange with a vastus lateralis free flap.This was followed by an extensor tendon reconstruction utilizing a free tensor fascia lata (tfl) flap and a subsequent washout procedure post-free flap reconstruction.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 17MM HEIGHT SIZE D ART. 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: 20733485
• Report Number: 0001822565-2024-03642
• Device Sequence Number: 8304835
• Product Code: JWH
• UDI-Device Identifier: 00889024199323
• UDI-Public: (01)00889024199323(17)250810(10)64723632
• 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: 2022
• 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): 02/18/2025

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 Expiration Date: 08/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588004017
• Device Lot Number: 64723632
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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
• Patient Weight: 106 KG