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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Event or Problem Description
It was reported that after the patient underwent a right total hip replacement, it was found that the patient had osteoporotic bone quality and sustained a non-displaced calcar fracture during stem impaction.Two 1.7mm cerclage cables were placed intraoperatively.Surgery completed without further complications.No additional information was available at the time of this report.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Device is used for treatment.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right hip tha was performed on (b)(6) 2022.During the impaction of the stem, the patient sustained a calcar fracture.It was noted the patient has osteoporotic bone quality.The fracture was reduced with cables and no other complications noted.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5;g3; h2 the following sections were corrected: b2; d1; d5; h8.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 during surgery, the patient, patient had osteoporotic bone quality, sustained a non-displaced calcar fracture during stem impaction.Careful inspection of the medial calcar confirmed that no fracture occurred during broaching.Two 1.7mm cerclage cables were placed intraoperatively and the surgery was completed without further complications.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) -stem.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: during the procedure, careful inspection of the calcar confirmed that the fracture did not occur while broaching.After the stem had been placed, inspection of the femur confirmed a non-displaced calcar fracture.Review of the device history record had identified no deviations or anomalies during manufacturing.The root cause remains unchanged.This complaint was confirmed based on the provided medical records.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
• Common Device Name: PROSTHETIC, 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: 15985855
• Report Number: 0001822565-2022-03482
• Device Sequence Number: 5798420
• Product Code: LZO
• UDI-Device Identifier: 00889024509047
• UDI-Public: (01)00889024509047(17)270419(10)3104660
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 574201050
• Device Lot Number: 3104660
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/30/2022; 05/16/2023; 07/29/2025
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/04/2023; 06/12/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 54 KG