MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TM POROUS UNCEMENTED WITH UNI-HOLE SHELL USE WITH KK LINERS; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to persistent pain related to the acetabular cup verticalization and muscle impingement.During the surgery, the surgeon identified a fracture at the top of the trochanter that was thought to be from the previous surgery.The cup, head, and liner were revised and wires were placed at the fracture site.The procedure was completed without complication and the stem remained implanted.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00877503604 item name biolox delta, ceramic femoral head lot # unknown.00877501236 item name biolox delta ceramic taper liner lot # 2869495.G2: foreign: france.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: it was reported a patient had an initial left total hip arthroplasty, subsequently, the patient was revised due to pain and muscle impingement.The trochanter had fractured from the previous operation as well.The head, shell, and liner were explanted and replaced with unknown products.A definitive root cause cannot be determined.It is unknown if the cup was placed with more of a vertical orientation based on the surgeon discretion or if it migrated.This complaint was confirmed based on the provided medical records.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.

• Brand Name: CONTINUUM TM POROUS UNCEMENTED WITH UNI-HOLE SHELL USE WITH KK LINERS
• 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: 20291406
• Report Number: 0001822565-2024-03055
• Device Sequence Number: 12761507
• Product Code: JDI
• UDI-Device Identifier: 00889024151420
• UDI-Public: (01)00889024151420(17)260930(10)63475179
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• 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
• Report Date (Section B): 05/15/2024

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 Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00875705600
• Device Lot Number: 63475179
• 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: 10/06/2022
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Weight: 107 KG