MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X46

Catalog Number 25060.2846

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 january 2019: lot 180438: (b)(4) items manufactured and released on 25-jun-2018.Expiration date: 2023-06-10.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.Cocr ball head 12/14 ø 28 size m 0 reference 01.25.012 (k072857): lot 183115: (b)(4) items manufactured and released on 07-aug-2018.Expiration date: 2023-07-18.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 Description

About 1 month after primary for an infection case the surgeon surgeon washed out the hip and revised the bipolar head and cocr head.The surgery was completed successfully.

• Brand Name: BIPOLAR HEAD Ø28X46
• Type of Device: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8252592
• MDR Text Key: 133214744
• Report Number: 3005180920-2018-01099
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Catalogue Number: 25060.2846
• Device Lot Number: 180438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention