MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

Model Number	01.25.015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Waiting more details from the branch about the products involved and type of event.
Event or Problem Description
The patient had a primary hip surgery on 18 dec 2019.Subsequently, the head dislocated from the liner.On (b)(6) 2022, the surgeon revised the head and liner.(b)(4).Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2022, the surgeon performed a washout and revised the head and liner.(b)(4).Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2023, the surgeon performed a washout, revised all implants.(b)(4).Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On 28 aug 2023, the surgeon performed a washout, revised all implants.(b)(4).Subsequently, the patient came in due to a dislocation of the head from the liner.On (b)(6) 2023, the surgeon revised the head and liner and implanted a dm converter.(b)(4).On (b)(6) 2025, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.On (b)(6) 2025 the surgeon revised the medacta stem with a competitor stem, and revised the medacta head and liner to a medacta dm.
Additional Manufacturer Narrative
Batch review performed on 22 december 2025.Ball heads: cocr 01.25.015 cocr ball head 12/14 ø 28 size xxl +10.5 (k072857) lot 1901505: (b)(4) items manufactured and released on 26-june-2019.Expiration date: 2024-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact dm 01.26.2852mhc double mobility hc liner ø28/dmf (k092265) lot 2302832: (b)(4) items manufactured and released on 12-april-2023.Expiration date: 2028-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional information: d1 d2 d4 g4 h4.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5
• 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: 23221255
• Report Number: 3005180920-2025-00922
• Device Sequence Number: 9568352
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 06/12/2024
• Device Model Number: 01.25.015
• Device Lot Number: 1901505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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 Age: 63 YR
• Patient Sex: Male