MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZUK PRC FEM SZE LMED/RLAT; PROSTHESIS, KNEE

Catalog Number	00584201501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in switzerland.H6: suggested component code mechanical (g04) - femur.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 a patient had a revision surgery due to a femoral implant fracture.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon receipt of additional information, it was determined this event was reported under mdt983151 0001822565-2026-00607.This is a duplicate report and should be voided.
Additional Manufacturer Narrative
Follow up report updated/corrected: b4,b5,d2,g1,g3,g6,h1,h2 upon receipt of additional information, it was determined this event was reported under mdt983151 0001822565-2026-00607.This is a duplicate report and should be voided.

• Brand Name: ZUK PRC FEM SZE LMED/RLAT
• 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: 24640264
• Report Number: 0001822565-2026-00853
• Device Sequence Number: 18588505
• Product Code: HSX
• UDI-Device Identifier: 00889024193789
• UDI-Public: (01)00889024193789(17)260630(10)63390430
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 06/30/2026
• Device Catalogue Number: 00584201501
• Device Lot Number: 63390430
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2016
• 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: Male