MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53

Catalog Number 25060.2853

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05 march 2019: lot 145525: (b)(4) items manufactured and released on 29-oct-2014.Expiration date: 2019-09-30.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 166587: (b)(4) items manufactured and released on 08-mar-2017.Expiration date: 2022-02-22.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

A revision surgery (washout and change of bipolar head and femoral head) after over a month has been successfully performed for suspected infection (pathogen not yet confirmed).

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53
• 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: 8394721
• MDR Text Key: 137961515
• Report Number: 3005180920-2019-00122
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843778
• UDI-Public: 07630030843778
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/06/2019

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: 09/30/2019
• Device Catalogue Number: 25060.2853
• Device Lot Number: 145525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2014
• 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
• Patient Age: 68 YR
• Patient Weight: 90