MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DUAL MOB BEARING 28MM I.D. 44MM O.D. SIZE F; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 00877502802 lot# 3118907 biolox⮠delta, ceramic femoral head, m, 㸠28/0, taper 12/14.G2: foreign: japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon did not approve the return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip procedure.Subsequently, the patient underwent a revision procedure approximately 10 months later due to dissociation.Attempts have been made and no further information has been provided.

• Brand Name: VIVACIT-E DUAL MOB BEARING 28MM I.D. 44MM O.D. SIZE F
• Type of Device: 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: 19144037
• MDR Text Key: 340603515
• Report Number: 0001822565-2024-01341
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)250630(10)64777279
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031012
• Device Lot Number: 64777279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention