MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIVACIT-E; PROSTHESIS, HIP

Catalog Number	30104008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unk screws; cat: 110010249 lot: 7024716 g7 osseoti 4 hole shell.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the procedure, the cup was implanted with three screws.A liner was attempted to be implanted and would not mate with the cup.A second liner was opened and also would not mate with the cup.Trying to place the liner resulted in the cup losing fixation.The shell and screws were removed and a second, larger cup was implanted.The liner would still not mate with the cup.A third liner was able to be implanted into the second cup.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10 visual examination of the returned product identified both liners have scratches and gouges to the i.D., top flat, and o.D.Surfaces.No other damage was noted during visual evaluation.Where measured, the liners were conforming to specifications.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided.Review of the available records identified the following: an initial left tha was performed.Trialing was successful without difficulty.When attempting to place the liner, it would not seat.This caused the cup to become dislodged, so a new cup was placed after additional reaming.The liner would not seat again after multiple attempts.Dual mobility was then placed without difficulty.A definitive root cause cannot be determined.This complaint cannot be confirmed.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.

• Brand Name: G7 VIVACIT-E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22108328
• Report Number: 0001822565-2025-01602
• Device Sequence Number: 12581835
• Product Code: LPH
• UDI-Device Identifier: 00889024519985
• UDI-Public: (01)00889024519985(17)291106(10)67005122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 30104008
• Device Lot Number: 67005122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Female