MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEADS; COCR BIPOLAR HEAD Ø28X48

Model Number	25060.2848
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 nov 2025.Ball heads: bipolar head 25060.2848 cocr bipolar head d 28x48 (k091967) lot.2410246: (b)(4) items manufactured and released on 12-sept-2024.Expiration date: 25-aug-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
After two months from the primary surgery, the bipolar head dislocated from the acetabulum.The surgeon revised the implant, converting the bipolar system to a total hip arthroplasty.

• Brand Name: BIPOLAR HEADS
• Common Device Name: COCR BIPOLAR HEAD Ø28X48
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23615344
• Report Number: 3005180920-2025-01165
• Device Sequence Number: 13004049
• Product Code: KWY
• UDI-Device Identifier: 07630030843679
• UDI-Public: 07630030843679
• Combination Product (Y/N): N
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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 Model Number: 25060.2848
• Device Lot Number: 2410246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2024
• 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: 86 YR
• Patient Sex: Female