MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X51

Model Number 25060.2851

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

Patient Problem Joint Dislocation (2374)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 may 2021: lot 1811811: (b)(4) items manufactured and released on 20-may-2019.Expiration date: 2024-05-05.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.Clinical evaluation performed by medical affairs director: few days after partial hip replacement, the bipolar head dislocated from the natural acetabulum of the patient.The surgeon decided then to transform the partial hip to a total hip and therefore the components were explanted.No reason to suspect any device deficiency as the main cause for this reoperation.

Event Description

Revision surgery performed 11 days after the primary due to bipolar head luxation posteriorly from the acetabulum.The surgeon successfully revised the bipolar head, cocr head and stem.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X51
• 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: 11973431
• MDR Text Key: 255328357
• Report Number: 3005180920-2021-00476
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843730
• UDI-Public: 07630030843730
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: 25060.2851
• Device Catalogue Number: 25060.2851
• Device Lot Number: 1811811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• 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