MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; FEMORAL HEAD Ø 32 SIZE M

Model Number	01.25.022
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-oct-2024.Lot 1902380: (b)(4) items manufactured and released on 13-sep-2019.Expiration date: 2024-09-02.No anomalies found related to the problem.To date, 131 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 4 years and 9 months after primary, the patent came in reporting pain due to a joint luxation and the cause is unknown.The surgeon revised the head and the surgery was completed successfully.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: FEMORAL HEAD Ø 32 SIZE M
• 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: 20493064
• Report Number: 3005180920-2024-00858
• Device Sequence Number: 17167797
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 09/02/2024
• Device Model Number: 01.25.022
• Device Lot Number: 1902380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female