MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 36 SIZE XL +7; HIP BALL HEAD

Catalog Number	01.25.033
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 september 2024: lot 2102840: (b)(4) items manufactured and released on 09-jun-2021.Expiration date: 2026-05-27.No anomalies found related to the problem.To date, 5 items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 06 september 2024: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2346403: (b)(4) items manufactured and released on 02-jan-2024.Expiration date: 2028-12-13.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.(note: the other case on this lot is on the same patient, where the liner dislocated from the head, but only the head was revised.).
Event or Problem Description
The patient had a primary on (b)(6) 2024.On (b)(6) 2024 due to a fall and dislocation, the head was revised to another medacta head.On (b)(6) 2024 the patient was revised for a dislocation and the cause is unknown.The surgeon revised the head, cup and liner.The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 36 SIZE XL +7
• Common Device Name: HIP 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: 20320102
• Report Number: 3005180920-2024-00775
• Device Sequence Number: 15399352
• Product Code: JDI
• UDI-Device Identifier: 07630030805233
• UDI-Public: 07630030805233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• Device Catalogue Number: 01.25.033
• Device Lot Number: 2102840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• 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