MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7; INSTRUMENT, HIP

Catalog Number	110003452
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.Visual examination of the returned product identified the locking geometry surfaces have nicks and indentations, a small portion around the locking slot is fractured.Both the small and large hex ends have nicks and scratches as well as small flats are present on the threads.No other damage was noted.The inserter was not returned.Where measured, the device was conforming to specifications, however the damage to the device prevents a functional test from being performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event for the shaft.Medical records were not provided.A definitive root cause cannot be determined.The threaded shaft was returned fractured; however, it is unknown when this damage occurred and how it may have affected the devices interaction.Unable to confirm the 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.
Event or Problem Description
It was reported the threaded shaft became stuck inside the inserter.Attempts were made to remove the shaft but were unsuccessful.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: G7
• Common Device Name: INSTRUMENT, 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: 23480723
• Report Number: 0001825034-2025-03487
• Device Sequence Number: 13344706
• Product Code: PBI
• UDI-Device Identifier: 00880304551602
• UDI-Public: (01)00880304551602(11)171024(10)052389
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 Catalogue Number: 110003452
• Device Lot Number: 052389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• 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: 07/23/2024
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2017
• 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
• Patient Sex: Unknown