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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ japan the customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not approved for return by the surgeon.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 after the surgeon inserted the liner, it appeared to go deeper than normal.When the surgeon removed the liner, the liner edge was damaged.A second liner was able to be inserted normally.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.Visual examination of the provided pictures identified about half of the scallops on the liner have been broken off from impacting the liner into the shell without the liner being properly aligned.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to user error by off label use and not following the surgical technique.As per surgical technique, it states to ensure the scallops are correctly aligned with the recessed areas on the shell before impacting.The damage to the scallops from the provided pictures indicates the liner was not properly aligned prior to impacting.This complaint was confirmed based on the provided picture of the damaged liner.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 further information is available at the time of this report.

• Brand Name: G7 ACETABULAR SYSTEM VIVACIT-E LINER
• 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: 20252984
• Report Number: 0001822565-2024-03022
• Device Sequence Number: 18370904
• Product Code: LPH
• UDI-Device Identifier: 00889024519824
• UDI-Public: (01)00889024519824(17)290214(10)66496508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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 Model Number: N/A
• Device Catalogue Number: 30103202
• Device Lot Number: 66496508
• Was Device Available for Evaluation?: No
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sex: Unknown