MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEADS; BALL HEADS: BIPOLAR HEAD 25060.2850 BIPOLAR HEAD Ø28X50

Model Number	25060.2850
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2025.Lot 2100466: (b)(4) items manufactured and released on 21-apr-2021.Expiration date: 2026-04-07.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.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
The patient had a link (competitor) proximal femoral replacement (stem and head) with a medacta bipolar shell.On the (b)(6) 2025, at about 1 month from the primary (on (b)(6) 2025), the patient dislocated bipolar head from the native acetabulum.The surgeon performed an open surgical procedure to relocate the prosthesis and during the case went from a 49 to a 50mm bipolar shell for added stability.The surgery was completed successfully.Complaint (b)(4) was filled.On (b)(6) 2025, the patient had pain after hip luxation because of the lack of abductor tension.Because the patient had a hemiarthroplasty, the surgeon removed acetabular osteophytes, opened the acetabulum medially, and implanted a smaller bipolar shell.He also changed the anteversion of proximal femoral replacement to aid with hip stability.The surgery was completed successfully.

• Brand Name: BIPOLAR HEADS
• Common Device Name: BALL HEADS: BIPOLAR HEAD 25060.2850 BIPOLAR HEAD Ø28X50
• 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: 22156484
• Report Number: 3005180920-2025-00483
• Device Sequence Number: 15663989
• Product Code: KWY
• UDI-Device Identifier: 07630030843716
• UDI-Public: 07630030843716
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: 04/07/2026
• Device Model Number: 25060.2850
• Device Lot Number: 2100466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• 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: Male