MAUDE Adverse Event Report: Zimmer Biomet, Inc. VIVACIT-E DM BEARING 28X40MM; Prosthesis, Hip

Catalog Number	110031010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 1-year post-implantation due to joint dislocation.Initially, the surgeon attempted to reduce the dislocation; however, an intraprosthetic dislocation occurred.Subsequently, the liner and dm bearing were revised.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).D10: g7 dual mobility liner 40mm d.Item: 110024462.Lot: 67465498.28mm mod hd std neck tp1 taper.Item: 163662.Lot: j7935144.G2: foreign, japan.The customer indicated that the product was discarded; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: VIVACIT-E DM BEARING 28X40MM
• 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 ; +1(574)526-0384
• MDR Report Key: 50460389
• Report Number: 0001822565-2026-02974
• Device Sequence Number: 15927272
• Product Code: LPH
• UDI-Device Identifier: 00889024572683
• UDI-Public: (01)00889024572683(17)300803(10)67445049
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 110031010
• Device Lot Number: 67445049
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown