MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 01.25.021 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5; HIP COCR BALL HEAD

Catalog Number 01.25.021

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 december 2023: lot 2308541: (b)(4) items manufactured and released on 24-may-2023.Expiration date: 2028-05-09.No anomalies found related to the problem.To date, 31 items of the same lot have been sold without any similar reported event in the period of review.Other device involved: liner: mpact 01.32.3239hct flat pe hc liner 32/c (k103721) lot 2309697: (b)(4) items manufactured and released on 13-june-2023.Expiration date: 2028-09-20.No anomalies found related to the problem.To date, 39 items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Hip instability due to a dislocation of the head from the liner.About 1 month post primary the surgeon revised the medacta head with another medacta head and the medacta cup and liner were revised to a competitor's product.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR 01.25.021 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Type of Device: HIP COCR 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: 18380308
• MDR Text Key: 331177590
• Report Number: 3005180920-2023-01046
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• 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: 12/21/2023

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: 01.25.021
• Device Lot Number: 2308541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• 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 Sex: Female