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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-01046
• Device Sequence Number: 7713306
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2308541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female