MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 22.2X36MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 1 month and 21 days post implantation due to intra-prosthetic luxation.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, d9, g3, g6, h2, h6, h11.Corrected: h4.One vivacit-e dm bearing 22.2x36mm item# 110031314 lot# 66312118, was returned.Upon visual inspection of only the bearing and head there are visible indentations to the od of the bearing with no damage to the lip of the device.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with superior and likely posterior dislocation as well as status post reduction on the fourth image.A definitive root cause cannot be determined.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).D10: 00-8018-022-20 item name femoral head - 2x22mm lot number unknown, unknown cup g2: foreign: belgium 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.

• Brand Name: VIVACIT-E DM BEARING 22.2X36MM
• Common Device Name: PROSTHETIC, 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: 19742556
• Report Number: 0001822565-2024-02368
• Device Sequence Number: 14375068
• Product Code: LPH
• UDI-Device Identifier: 00889024572829
• UDI-Public: (01)00889024572829(17)290111(10)66312118
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/11/2024

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 Model Number: N/A
• Device Catalogue Number: 110031314
• Device Lot Number: 66312118
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose