MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 6; 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); Pain (1994)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a week post implantation it was found that the implant had collapsed 0.5 cm more than the final broach.The intra op x-ray did not show anything because the patient was in so much pain for a few days post implantation so a ct scan was taken and showed a fracture of the femur.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: belgium.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, a supplemental medwatch will be submitted h3 other text : device remains implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records 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: nondisplaced periprosthetic fracture of the femoral diaphysis ventrally.A definitive root cause cannot be determined.It is unknown if the stem not seating properly was related to the bone fracture, and when exactly the bone fracture occurred as the reporter indicated the intra op x-rays didn't show anything.However, the pain and fracture was only reported a few days post op.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 STD NC SIZE 6
• 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: 18623447
• Report Number: 0001822565-2024-00330
• Device Sequence Number: 20694142
• Product Code: LZO
• UDI-Device Identifier: 00889024508668
• UDI-Public: (01)00889024508668(17)271025(10)3124895
• 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: 2024
• 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): 06/07/2024

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: 574101060
• Device Lot Number: 3124895
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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: Unknown
• 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: Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Male