MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA.; PROSTHESIS, HIP

Catalog Number	00662406530
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)(4).G2: australia.D10: cat #: 11-107122 / freedom all poly cup 50mm / lot #: 191490.Cat #: 010001004 / g7 screw 6.5mm x 60mm / lot #: 3895696.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.Visual examination of the provided pictures identified an explanted bearing with head assembled within, covered in biodebris.Further observations cannot be made based on the image alone due to reduced image quality.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional and 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.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." based on the medical image 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
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.

• Brand Name: BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21584291
• Report Number: 0002648920-2025-00067
• Device Sequence Number: 9467425
• Product Code: JDI
• UDI-Device Identifier: 00889024127661
• UDI-Public: (01)00889024127661(17)311027(10)65140220
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K840643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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
• Device Catalogue Number: 00662406530
• Device Lot Number: 65140220
• 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: 03/05/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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
• 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