MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: cemented tibial component catalog # 00588000500 lot # 65245291 offset stem extension catalog # 00598802014 lot # 64516428 articular surface with hinge post extension catalog # 00588006012 lot # 65154693 g2: spain h3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2023-03589 0001822565-2023-03593 0001822565-2023-03595 h3 other text : discarded.
Event or Problem Description
It was reported patient underwent a revision procedure post implantation due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
Upon receipt of additional information, patient was revised due to mobility of the tibia.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of additional information, patient was revised due to mobility of the tibia.The initial report was submitted in error and should be voided.

• Brand Name: 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: 18317212
• Report Number: 0001822565-2023-03594
• Device Sequence Number: 6152621
• Product Code: KRO
• UDI-Device Identifier: 00889024199163
• UDI-Public: (01)00889024199163(17)260728(10)64996808
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013385
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 07/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 00588001601
• Device Lot Number: 64996808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown