MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DUAL MOBILITY VIVACIT-E; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 802202802 zb 12/14 cocr hd 28mm x +0 67096229.G2: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 the initial surgery was performed using a g7 dual mobility (dm) system.A reoperation was later performed due to an intraprosthetic dislocation (ipd).On this occasion, further dislocation occurred.A revision procedure was completed to replace the bearing and femoral head.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h6; h10.The following sections were corrected: b5 for clarification and formatting; b7; d1.Visual inspection of the returned items performed.The size, item number and lot number etching is confirmed on the head however there is no etch to be verified on the bearing per print.The devices were returned no longer assembled with each other.The head has scratches and scuffs on the o.D.The bearing has gouges and scratches present on the top flat surface, inside chamfer, and o.D.Along with scratches inside the i.D.Dimensional inspection was performed and measurements were found to be conforming.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Complaint is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that approximately 6 month post-hip procedure, the patient underwent a hip revision due to dislocation to replace the head and bearing.Attempts have been made and no further information has been provided.

• Brand Name: DUAL MOBILITY VIVACIT-E
• Common Device Name: PROSTHESIS, HIPS
• 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: 23802524
• Report Number: 0001822565-2025-04498
• Device Sequence Number: 13079068
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)291218(10)67075135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/18/2026

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 Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 67075135
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown