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

Catalog Number	574777110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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 during the procedure, the extractor adapter broke while attempting to remove the stem.The stem was unable to be removed and the patient retained a foreign body from the broken instrument.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: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified the threaded tip is fractured at the base of the threads, no fractured pieces returned with device.There are minor scratches and nicks to the knurled surface.No other damage was noted during visual evaluation.The device was submitted for further analysis.Analysis determined that the device possibly fractured due to bending overload.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to the surgeon failing to follow the instructions in the surgical technique of how to use the instrument.As per the surgical technique, it states under the intraoperative stem repositioning or removal, that once the extractor adapter is assembled, to "pull the stem out in line with the femoral shaft by using the slide hammer." as this device was identified to have bending overload as the failure, the device was not used properly or "in line with the femoral shaft." this complaint was confirmed based on the returned, fracture device.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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: AVENIR COMPLETE
• Common Device Name: INSTRUMENT, 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: 21876740
• Report Number: 0001822565-2025-01090
• Device Sequence Number: 7719316
• Product Code: KWY
• UDI-Device Identifier: 00889024509825
• UDI-Public: (01)00889024509825(11)240213(10)66354118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 574777110
• Device Lot Number: 66354118
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male