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

Catalog Number	110031013
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three weeks post-implantation, the patient underwent a hip revision due to dislocation.
Additional Manufacturer Narrative
(b)(4).D10: cat: 110024465 lot: 66758341 g7 dual mobility liner 46mm g.G2: foreign ¿ japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h4; h6.Visual examination of the provided pictures identified a shell, bearing, head, liner, and screw.The shell appeared to have scratches on the flat surface.No further evaluation could be made from the provided pictures.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.This complaint cannot be 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h6.Visual examination of the returned product identified ceramic head was retuned seated in the bearing.Indentations, gouges, and scratches are present on the outer spherical surface.Rim has deformation and gouge damage.No other damage was noted.Root cause unchanged.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
No further information is available at the time of this report.

• Brand Name: VIVACIT-E
• 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: 22836067
• Report Number: 0001822565-2025-02994
• Device Sequence Number: 15764764
• Product Code: LPH
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713(17)300122(10)67109075
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 110031013
• Device Lot Number: 67109075
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 03/24/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/09/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown