MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIVACIT-E 36MM I.D. SIZE G 10A LINER; PROSTHESIS, HIP

Catalog Number	30113607
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10:cat# 11-363661 lot# j7133171 36mm cocr mod hd -3mm.G2: foreign: chile.The 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 that an initial left total hip arthroplasty was performed.Subsequently, the patient was revised approximately 3 years later due to pain and difficulty ambulating from poly liner wear and dislocation.The head and liner were replaced while the stem and cup remain intact.It was reported that no further information is available.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified gouges, wear, scratches, deformation, and missing features due to damage during use.Cutouts and anti rotation scallops have worn off / deformed on the lower elevated rim side.Remaining cutouts and anti rotation scallops are deformed.Inner and outer spherical surfaces show abnormal wear damage.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had an initial left tha.The patient had a ct scan and acetabular component, and femoral stem was in good position.There was intra-acetabular displacement of the femoral head suggesting wear of the liner.The patient had a revision due to dislocation, pain and difficulty walking.A definitive root cause cannot be determined.Based on the provided medical records and returned product review, the complaint is 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 36MM I.D. SIZE G 10A 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: 21397346
• Report Number: 0001822565-2025-00368
• Device Sequence Number: 15349904
• Product Code: LPH
• UDI-Device Identifier: 00889024520219
• UDI-Public: (01)00889024520219(17)251014(10)64909119
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 06/11/2025

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 Expiration Date: 10/14/2025
• Device Catalogue Number: 30113607
• Device Lot Number: 64909119
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male