MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X52; HIP BIPOLAR HEAD

Model Number	25060.2852
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 april 2020: lot 1904863: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-04.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold without any similar reported event.Additional device involved in the complaint: batch review performed on 17 april 2020: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot 1905316: (b)(4) items manufactured and released on 26-nov-2019.Expiration date: 2024-11-16.No anomalies found related to the problem.To date, 99 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a dislocation of the bipolar component from the ball head.The cause of the dislocation is unknown.1 month after primary surgery the surgeon revised the bipolar head 52mm/28 with a bipolar head 53mm/28 and left the 28mm cocr head s and quadra-p std.Size 4 stem as they were stable.The surgery was completed successfully.

• Brand Name: BIPOLAR HEAD Ø28X52
• Common Device Name: HIP BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10023935
• Report Number: 3005180920-2020-00270
• Device Sequence Number: 19511661
• Product Code: KWY
• UDI-Device Identifier: 07630030843754
• UDI-Public: 07630030843754
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2024
• Device Model Number: 25060.2852
• Device Catalogue Number: 25060.2852
• Device Lot Number: 1904863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/05/2020
• 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