MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD 28X46

Model Number	25060.2846
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 9 octorber 2020 lot 1905674: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-13.No anomalies found related to the problem.To date, 78 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain, 2 two months after the primary surgery, due to a dislocation of the bipolar head from the acetabulum.The surgeon revised the bipolar head size 28x46 with a bipolar head size 28x46 and the 28mm cocr head m with a 28mm cocr head l.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD 28X46
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10727243
• Report Number: 3005180920-2020-00741
• Device Sequence Number: 3345577
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 01/13/2025
• Device Model Number: 25060.2846
• Device Catalogue Number: 25060.2846
• Device Lot Number: 1905674
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 10/23/2020
• 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