MAUDE Adverse Event Report: ZIMMER GMBH DUROM FEMORAL COMPONENT; HIP, PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report 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 Description

It was reported that patient underwent left hip revision approximately 7 years post implantation due to advanced osteoarthritis and pain.No contributing conditions related to the event.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected disease progression of osteoarthritis can continue in native bone structures as a patient continues to ages.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patients risk for progressive osteoarthritis.Patients with disease progression of osteoarthritis in the affected joint develop pain, and decrease in joint flexibility.As osteoarthritis progresses to the previously unaffected area of the hip with deterioration to a point in which the patient and doctor may elect to take an approach to a hip replacement to alleviate the symptoms of pain.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: DUROM FEMORAL COMPONENT
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18355661
• MDR Text Key: 330882545
• Report Number: 0009613350-2023-00699
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 00889024422865
• UDI-Public: (01)00889024422865(17)110930(10)2347485
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 0100211150
• Device Lot Number: 2347485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 77 KG