MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD Ø28X47

Catalog Number	25060.2847
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 april 2024.Lot 2248235: (b)(4) items manufactured and released on 15-jun-2023.Expiration date: 2028-05-23.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.Clinical evaluation performed by medical affairs director.Revision 3 weeks from the partial hip arthroplasty.The bipolar head dislocated from the acetabulum.The surgeon found all components stable even when he reduced intraoperatively.Then, he revised the femoral head to a xxl and a new 47mm bipolar head.Luxation is a possible literature described adverse event and it may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.
Event or Problem Description
At 3 weeks from the primary, the patient came in reporting pain due to a dislocation of the bipolar head from the acetabulum.The surgeon found all components stable even when he reduced intraoperatively.He revised the femoral head to a xxl and a new 47mm bipolar head.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD Ø28X47
• Common Device Name: BIPOLAR 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: 19266711
• Report Number: 3005180920-2024-00265
• Device Sequence Number: 20692963
• Product Code: KWY
• UDI-Device Identifier: 07630030843655
• UDI-Public: 07630030843655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091967
• 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): 05/08/2024

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 Catalogue Number: 25060.2847
• Device Lot Number: 2248235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 136 KG