MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA HO NC SIZE 8; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total hip arthroplasty, the patient suffered an intraoperative fracture of the femur.The fracture occurred during impaction of the stem and was visible on fluoroscopy.Calcar remained intact.3 cerclage wires were placed, and all implants remain implanted.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
Cmp-0898901 d10: 00877503602 item name: biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper: 12/14.Lot #: 315686101000706.Item name: g7 shell 58 bone master.Lot #: 749263830103607.Item name: g7 vit e neutral lnr 36mm g.Lot #: 65741105.Unknown cerclage wires x3.G2: foreign: belgium.The device will not be returned for analysis as device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h3 h6 proposed component code: mechanical (g04)- stem h10 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left tha with possible early linear fracture in the medullary space at the tip of the femoral stem on the 6 weeks postop film with further progression on the intraoperative fluoro.This complaint was confirmed based on the provided x-rays.A definitive root cause cannot be determined.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
There is no update to the prior event description provided.

• Brand Name: AVENIR CMPL HA HO NC SIZE 8
• 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: 17878269
• Report Number: 0001822565-2023-02712
• Device Sequence Number: 7695552
• Product Code: LZO
• UDI-Device Identifier: 00889024508835
• UDI-Public: (01)00889024508835(17)260615(10)3070257
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 11/17/2023

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 Expiration Date: 06/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 574102080
• Device Lot Number: 3070257
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose