MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED INSERTER THD SHAFT; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 110010248 g7 osseoti 4 hole shell 60mm g 66852932.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 the curved inserter threaded shaft screw broke while trying to disengage the inserter handle from the acetabular cup implant while it was in the patient.The surgeon removed the cup from the patient and implanted a new cup.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d10, g3, g6, h2, h3, h4, h6.D10: 110010248 g7 osseoti 4 hole shell 60 mm g 66852932.110003454 g7 curved inserter thd shaft unknown.010002749 g7 straight mod scrdrvr 3.5 mm zb180501.Visual examination of the returned product identified wear from previous uses in the hex for the threaded shaft.Device is fractured.Distal threaded tip remains in the shell.Proximal side with hex was returned loose.Shell outer spherical diameter, rim, and inner spherical surface have damage from attempted use and to be separated from instruments.No other damage was noted.Nicks and scratches are noted from previous uses for the screwdriver.Hex tip is confirmed to have fractured off and remains in the inserter threaded shaft in the shell.Dhr was not reviewed as no problem was found with the inserter.Medical records were not provided.No problem was found with the inserter as it was not involved in the interaction issue with the cup and threaded shaft.This complaint was confirmed based on the returned devices.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 CURVED INSERTER THD SHAFT
• Common Device Name: HIPS, INSTRUMENTS
• 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: 21364684
• Report Number: 0001825034-2025-00345
• Device Sequence Number: 8437395
• Product Code: PBI
• UDI-Device Identifier: 00880304543324
• UDI-Public: (01)00880304543324(11)210419(10)635870
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• 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,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003453
• Device Lot Number: 635870
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 07/11/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/17/2025; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Male