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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.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 when attempting to screw the cup into the curved handle the black screw did not screw or unscrew properly.The surgeon stated that the cup was loose on the handle.The surgery was completed with a second screw in the set.No known impact or consequence to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d9, g3, g6, h2.
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 information.The following sections were updated: b4, b5, d4 (udi #), g3, g6, h2, h3, h4, h6, h11.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified the large internal hex is visually stripped and has indentation marks present.The leading thread has minor nicks and visually appears rolled.The locking rail has nicks and indentation damage.No other damage was noted during visual evaluation.This device has an approximate field age of 1.5 years.No functional evaluation performed due to visual damage present on functional surfaces.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.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 further event information is available at the time of this 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: 22982229
• Report Number: 0001825034-2025-02800
• Device Sequence Number: 21067389
• Product Code: PBI
• UDI-Device Identifier: 00880304543331
• UDI-Public: (01)00880304543331(10)083625
• 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): 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): 01/26/2026

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: 083625
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 01/14/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/20/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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