MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 PROV NEUTRAL LINER 32MM C; Prosthesis, Hip

Catalog Number	010002622
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the g7 liner provisional, size c (32 mm, neutral), the plastic portion of the trial liner broke during removal after completion of the trial reduction.No patient harm or impact was reported.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - japan.Visual examination of the returned product identified signs of use as well as wear and tear.There are gouges and knicks on the outside diameter and rim of the liner.Both tabs near the through hole have fractured as shown in the photos.The provisional screw was also returned with the device and had some light scratches and knicks on the on the top.Verified outside diameter and that the liner is visually conforming to print.The device has an approximate field age of 7 years.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 trends.

• Brand Name: G7 PROV NEUTRAL LINER 32MM C
• Common Device Name: Prosthesis, 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 ; +1(574)526-0384
• MDR Report Key: 50801391
• Report Number: 0001825034-2026-02797
• Device Sequence Number: 8643684
• Product Code: LPH
• UDI-Device Identifier: 00880304565654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Catalogue Number: 010002622
• Device Lot Number: Z18J1882
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• 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: 04/17/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown