MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 60MM; PROSTHESIS, HIP

Catalog Number	010001004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) g2: australia.D10: cat #: 11-107122 / freedom all poly cup 50mm / lot #: 191490; cat #: 00700006620 / 66mm cup size revision shell / lot #: 65566013; cat #: 00662406530 / bone screw self-tapping 30 mm length 6.5 mm dia./ lot #: 65140220; cat #: 00662406560 / bone screw self-tapping 60 mm length 6.5 mm dia./ lot #: 64776802; cat #: 802403603 / constrained head 12/14 taper 36 mm diameter +0 mm neck length for use with freedom constrained liners / lot #: 3089039.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient underwent a bilateral hip revision approximately one year and three months post implantation due to an acetabular fracture.The shells, screws and heads were removed and replaced.It was reported that no additional information on the reported event is unavailable at this time.
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.Visual examination of the provided pictures identified the explanted bearing and head remains assembled, and covered in bio debris.No further observations could be noted using the image provided.No product was returned; further 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 review of the available records identified the following: the right hip arthroplasty components are anatomically aligned.There is a suspected cortical defect of the medial acetabular wall correlating with the fracture described.The visualized acetabular fixation screws are intact.The incompletely visualized proximal femur and femoral implant appear normal and without fracture.A definitive root cause cannot be determined.Based on the x-ray review, the 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.
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.A definitive root cause cannot be determined.However, it is known that a freedom all poly cup was used with the tmars revision shell and this is considered off label use per ifu.It states under compatibility "do not use components of the trabecular metal acetabular revision system (tmars) with components of any other system or manufacturer unless authorized by zimmer biomet." as per freedom® constrained system ifu, "do not modify implants.Before using a product placed on the market by biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.G., product literature, surgical technique).Zimmer or biomet is not liable for complications that may arise from the use of the device in circumstances outside of zimmer or biomet¿s control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique." it is unknown if this off label use caused or contributed to the reported 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.

• Brand Name: G7 SCREW 6.5MM X 60MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20847626
• Report Number: 0001825034-2024-02858
• Device Sequence Number: 3771364
• Product Code: PBI
• UDI-Device Identifier: 00880304527522
• UDI-Public: (01)00880304527522(17)261007(10)3895696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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,Followup
• Report Date (Section B): 02/26/2025

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 Catalogue Number: 010001004
• Device Lot Number: 3895696
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/30/2025; 02/20/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/05/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female