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

Catalog Number	574102050
Medical Device Problem Codes	Difficult to Insert (1316); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: france.H6: component code: stem.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that following the replacement of the implant, the implant was sinking.The surgery was completed with a larger implant.There is no further information available at the time of this report.
Event or Problem Description
It was reported that during surgery, the stem implant failed and was reported as sinking.This was an opening error in the operating room.A larger implant was used to complete the procedure.There was no known impact or consequences to the patient.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: b5; d4; d9; e1; g3; h2; h6 the following sections were corrected: a2; d1 the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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: g3; h2; h3; h4.Visual examination of the returned product identified some discoloration was noted on the ha coated stem.Proximal end has gouges and damage.No other damage was noted.Dimensional product identifier for length of stem was measured and within specifications.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to user error as it was reported the wrong stem size was chosen and was opened in error.As per ifu, it states under precautions " visual inspection of the packaging is recommended prior to implantation so that the appropriate stem is selected for implantation."."zimmer biomet or its affiliates are not liable for complications and/or failure that may arise from use of the device in circumstances outside of zimmer biomet or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique".This complaint is 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 COMPLETE HIP SYSTEM
• 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: 22004891
• Report Number: 0001822565-2025-01343
• Device Sequence Number: 20638166
• Product Code: LZO
• UDI-Device Identifier: 00889024508781
• UDI-Public: (01)00889024508781(17)290829(10)3207053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 574102050
• Device Lot Number: 3207053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 10/01/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/16/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Male