MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X45

Model Number 25060.2845

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 january 2021 lot 1905682: (b)(4) items manufactured and released on "23-ott-2019".Expiration date: 2024-10-12.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 Description

Revision surgery performed due to bipolar head luxation from the acetabulum, 19 days after the primary.The surgeon revised the bipolar head and cocr head and the surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X45
• Type of Device: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11193068
• MDR Text Key: 227505698
• Report Number: 3005180920-2021-00053
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843617
• UDI-Public: 07630030843617
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25060.2845
• Device Catalogue Number: 25060.2845
• Device Lot Number: 1905682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2019
• 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