MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7® VIVACIT-E® 36MM I.D. SIZE F NEUTRAL LINER; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Discomfort (2330); Joint Dislocation (2374)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00-8775-036-01 item name biolox delta hd 12/14 36x-3.5 lot # 3167964.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision procedure 2 months post implantation due to recurrent dislocations with discomfort.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a4, b4, b5, d9, g3, g4, g6, h2, h8, h11.
Event or Problem Description
It was reported that the patient underwent a hip revision procedure 2 months post implantation due to recurrent dislocations with discomfort.During the revision the femoral stem and acetabular cup were found to be well ingrown and well positioned.The head and liner were revised without complications.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual review of the returned liner confirmed item, lot, and etch identification.Liner showed gouges, deformation, and indentations to the rim, cutouts, anti rotation scallops, and inner/outer spherical surfaces.Gouge on the sidewall was noted from possible tool mark.No other damage was noted.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: recurrent dislocation right total hip arthroplasty.A definitive root cause cannot be determined.This complaint can be confirmed via the provided medical records.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
There is no update to the prior event description provided.

• Brand Name: G7® VIVACIT-E® 36MM I.D. SIZE F NEUTRAL LINER
• Common Device Name: PROSTHETIC, 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: 20795207
• Report Number: 0001822565-2024-03738
• Device Sequence Number: 20580516
• Product Code: LPH
• UDI-Device Identifier: 00889024519916
• UDI-Public: (01)00889024519916(17)290710(10)66784231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 30103606
• Device Lot Number: 66784231
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 01/28/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/12/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG