MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROXIMAL FEMORAL COMPONENT 46 MM OFFSET; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the patient underwent a left hip revision due to unknown reasons.However, radiographs were reviewed and indicate a periprosthetic femur fracture.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).D10 ¿ medical products item# 00585205014, lot# 62677130: fluted stem extension straight precoat for cemented use only g2: foreign source: australia.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
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h4, h6, and h11.Corrections are in section d4.
Additional Manufacturer Narrative
Upon reassessment of the reported event, this proximal femoral component was determined to be not reportable.The initial report was forwarded in error and should be voided.Sections updated: b3, b4, b5, d6, g3, g6, h2, and h11.
Event or Problem Description
Upon reassessment of the reported event, this proximal femoral component was determined to be not reportable.Radiographs show the fracture occurred in the area of the stem component.The initial report should be voided.

• Brand Name: PROXIMAL FEMORAL COMPONENT 46 MM OFFSET
• 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: 19477068
• Report Number: 0001822565-2024-01911
• Device Sequence Number: 14471064
• Product Code: KRO
• UDI-Device Identifier: 00889024195851
• UDI-Public: (01)00889024195851(17)300531(10)64661427
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/20/2024

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: 00585003246
• Device Lot Number: 64661427
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/17/2024; 10/31/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/20/2024
• Date Device Manufactured: 06/02/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Male