MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X42MM; PROSTHESIS, HIP

Catalog Number	110031011
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 dual mobility liner 42mm e item: 110024463 lot: 043100 unknown head unknown stem unknown cup customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during an attempted closed reduction of the patient¿s dislocated hip, the bearing became disassociated.Subsequently, the patient underwent revision surgery and was converted to a freedom constrained liner.It was noted that the patient had prior spinal fusion surgeries.This elevates the risk for postoperative dislocations.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; d10; g3; h2; h3; h4; h6.D10 update: unknown depuy head (competitor).Visual inspection of the returned item # 110031011, lot # 65726137, vivacit-e dm bearing 28x42mm performed.Product identifiers were verified.The bearing has multiple circular shaped grooves in the o.D.Surface.There are scratches present all around the top flat surface.There is also a nick along with scratches present in the i.D.Dimensional analysis was performed and measurements taken were conforming.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.It was noted that a competitor head was used with the zimmer biomet bearing, and this is considered off-label use.However, it is unknown if the off-label use caused or contributed to the reported disassociation.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.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: VIVACIT-E DM BEARING 28X42MM
• 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: 23463896
• Report Number: 0001822565-2025-03973
• Device Sequence Number: 9084438
• Product Code: LPH
• UDI-Device Identifier: 00889024572690
• UDI-Public: (01)00889024572690(17)280106(10)65726137
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 110031011
• Device Lot Number: 65726137
• Was Device Available for Evaluation?: Yes
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown