MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM ALL POLY CUP 54MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00-2232-004-18 item name cable ready gtr cocr cable lot # 66418000 00-2232-004-18 item name cable ready gtr cocr cable lot # 66577127 00-2232-004-18 item name cable ready gtr cocr cable lot # 66418003 802403603 item name constrained head 12/14 taper 36 mm diameter +0 mm neck length for use with freedom constrained liners lot # 3171488 00-8114-004-23 item name cpt 12/14 sz 4 cocr 230mm ext lot # 64309680.G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a second stage revision procedure after a successful first stage due to unknown reasons.There is no additional information available.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, g3, g6, h2, h6, h8, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported event is attributed to the user not following instructions for use indicates under the contradictions section that the device should not be used if there are any active or suspected infection in or about the hip.Unable to confirm complaint.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: FREEDOM ALL POLY CUP 54MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20820276
• Report Number: 0001825034-2024-02800
• Device Sequence Number: 18105622
• Product Code: KWZ
• UDI-Device Identifier: 00880304203600
• UDI-Public: (01)00880304203600(17)260211(10)437070
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030047
• 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): 01/16/2025

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: Lay User/Patient
• Device Expiration Date: 02/11/2026
• Device Model Number: N/A
• Device Catalogue Number: 11-107124
• Device Lot Number: 437070
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose