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

Model Number	25060.2846
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2020: lot 1904859: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-04.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.
Event or Problem Description
Revision surgery performed due to dislocation of the bipolar head from acetabular bone.Ball head, head and stem were revised 1 month after primary.The patient fell but it is not known if the patient fell and luxated or vice-versa.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X46
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10331240
• Report Number: 3005180920-2020-00463
• Device Sequence Number: 19066546
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: No Information
• Device Expiration Date: 09/04/2024
• Device Model Number: 25060.2846
• Device Catalogue Number: 25060.2846
• Device Lot Number: 1904859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/28/2020
• 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
• Patient Age: 73 YR
• Patient Weight: 78