MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRILOGY ALLOFIT VIVACIT E; PROSTHESIS, HIP

Catalog Number	00885200832
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unk head g2: foreign ¿ canada.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 patient underwent a hip revision due to the fractured posterior lip of the liner.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1; b5; d4; d6a; g3; h2.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 approximately five years post-implantation, the patient underwent a hip revision due to the fractured posterior lip of the liner.It was reported that no further information is available.
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.The following sections were corrected: d4 udi.Visual examination of the provided pictures identified the explanted liner with most of the rim broken off, with a piece show in the provided picture.The device is covered in bio-debris.The explanted ceramic head shows metal transfer to the outer spherical surface, with explanted bio-debris shown as well.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CONTINUUM TRILOGY ALLOFIT 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: 22778910
• Report Number: 0001822565-2025-02876
• Device Sequence Number: 9342226
• Product Code: JDI
• UDI-Device Identifier: 00889024149670
• UDI-Public: (01)00889024149670(17)220630(10)63692410
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2025

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 00885200832
• Device Lot Number: 63692410
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 12/10/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/02/2025; 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2017
• 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