MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45; HIP BIPOLAR HEAD

Model Number 25060.2845

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 august 2022: lot 2002016: (b)(4) items manufactured and released on 18-jun-2020.Expiration date: 2025-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Other devices involved: batch review performed on 08 august 2022: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2009385: (b)(4) items manufactured and released on 22-jan-2021.Expiration date: 2026-01-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.At about 1 month post primary surgery the surgeon performed a washout and revised the head and the surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45
• Type of Device: HIP 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: 15348737
• MDR Text Key: 299171858
• Report Number: 3005180920-2022-00666
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: 2002016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• 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