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

Model Number	N/A
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the g7 thread could not be removed after cup insertion.The surgeon was able to remove the cup and inserter once on the table.Another g7 thread was used to complete the procedure.A ten (10) minute delay occurred.No known impact or consequence to the patient.
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, h2, h3, h6 the following section was corrected: h4 visual examination of the returned product identified the device has damage consistent with the reported event.Indentation marks around the locking rails, top flat surface of the head, and around the o.D.Of the head causing the rails to be bent and material to impede the locking slot.The large internal hex shows heavy wear marks.There are nicks present on the small hex end.No other damage was noted during visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 additional information to report.

• 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: 22951612
• Report Number: 0001825034-2025-02770
• Device Sequence Number: 21299187
• Product Code: PBI
• UDI-Device Identifier: 00887868462528
• UDI-Public: (01)00887868462528(11)220429(10)080474
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 110003454
• Device Lot Number: 080474
• Was Device Available for Evaluation?: Yes
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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