MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR; PROSTHESIS, HIP

Catalog Number	574103050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ denmark h6: suggested component code: mechanical (g04) - stem.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains imlpanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately two years post-implantation, the patient experienced trochanteric bursitis and was treated with a medical bloc.There was no revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a3; b5-b7; g3; h2; h6 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately two years post-implantation, the patient experienced trochanteric bursitis and thigh pain.Patient was treated with a medical bloc.There was no revision.Two blockades had only a minor effect.Patient is doing exercises with a physiotherapist and not using daily painkillers.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h4; h6.The following sections were corrected: h6 component code.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.The root cause of the reported event was determined to be unrelated to the device.Complaint is not confirmed.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: AVENIR
• Common Device Name: PROSTHESIS, HIP
• 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: 22885740
• Report Number: 0001822565-2025-03087
• Device Sequence Number: 8918921
• Product Code: LZO
• UDI-Device Identifier: 00889024508910
• UDI-Public: (01)00889024508910(17)260228(10)3064721
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 574103050
• Device Lot Number: 3064721
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 01/02/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/29/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female