MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 32SIZE S -3.5; HIP METALLIC BALL HEAD

Catalog Number 01.25.011

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 03/03/2022

Event Type  Injury  

Event Description

The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner that was caused from falling.The surgeon revised the cup, head, and liner.The surgery was completed successfully.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.(mdr 3005180920-2022-00216).Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 18 september 2023.Lot 2011588: (b)(4) items manufactured and released on 02-mar-2021.Expiration date: 2026-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional device involved: liner: versafitcup dm 01.26.2850mhc double mobility hc liner diam 50/28 (k092265) lot 2101757: (b)(4) items manufactured and released on 06-may-2021.Expiration date: 2026-04-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: COCR BALL HEAD 12/14 Ø 32SIZE S -3.5
• Type of Device: HIP METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17868927
• MDR Text Key: 324896175
• Report Number: 3005180920-2023-00774
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.25.011
• Device Lot Number: 162360B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 125 KG