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

Catalog Number	110031009
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat # 110024461 lot # 66507096 g7 dual mobility liner cat # 00877502802 lot # 3181452 bioloxâ® delta, ceramic femoral head 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 approximately six to nine months post-implantation, the patient underwent a hip revision due to subluxation.The patient reported cracking feeling in their hip and imaging displayed subluxation of the head.During the revision, it was noted that the head was too short and leading to the liner impacting on the stem.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that approximately nine months post-implantation, the patient underwent a hip revision due to subluxation.The patient reported cracking feeling in their hip and imaging displayed subluxation.During the revision, it was noted that the head was too short and leading to the liner impacting on the stem.There had been an error in measurement during the initial procedure leading to insufficient length in the head.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b3; b5; d6b; g3; h2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified explanted devices, these cannot be used to confirm the reported event.Devices not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: summary note; surgeon report - xr displayed subluxation of femoral head with respect to the metal cup.The image is confirmed in ct.Prior post-op xr did not show the complication.¿the images are not absolutely clear in showing the exact cause of this subluxation, there is suspicion that the dual mobility system has been decoupled.Root cause determined to be not device related as the notes state the head length was measured incorrectly leading to it being short and thus the events tied to the liner and bearing are secondary to the off label.Complaint is not 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.
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: 23896293
• Report Number: 0001822565-2025-04805
• Device Sequence Number: 5344641
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)290812(10)66828544
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 03/09/2026

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: 110031009
• Device Lot Number: 66828544
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/26/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/03/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female