MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X51

Model Number	25060.2851
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2021: lot 1811811: (b)(4) items manufactured and released on 20-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: few days after partial hip replacement, the bipolar head dislocated from the natural acetabulum of the patient.The surgeon decided then to transform the partial hip to a total hip and therefore the components were explanted.No reason to suspect any device deficiency as the main cause for this reoperation.
Event or Problem Description
Revision surgery performed 11 days after the primary due to bipolar head luxation posteriorly from the acetabulum.The surgeon successfully revised the bipolar head, cocr head and stem.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X51
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11973431
• Report Number: 3005180920-2021-00476
• Device Sequence Number: 19097426
• Product Code: KWY
• UDI-Device Identifier: 07630030843730
• UDI-Public: 07630030843730
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: 05/05/2024
• Device Model Number: 25060.2851
• Device Catalogue Number: 25060.2851
• Device Lot Number: 1811811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention