MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X45

Model Number	25060.2845
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 december 2019.Lot 1900862: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot.1903461.Batch review performed on 27 december 2019.Lot 1903461: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 23 days after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the bipolar head 45mm/28 and 28mm cocr head s.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X45
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9605381
• Report Number: 3005180920-2019-01162
• Device Sequence Number: 18969554
• Product Code: KWY
• UDI-Device Identifier: 07630030843617
• UDI-Public: 07630030843617
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: 05/27/2024
• Device Model Number: 25060.2845
• Device Catalogue Number: 25060.2845
• Device Lot Number: 1900862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/20/2020
• 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