MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5

Catalog Number 01.29.201

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 february 2018, lot 164973: (b)(4) items manufactured and released on 04 november 2016.Expiration date: 2021-10-25.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

Revision surgery due to signs of infection after 4 months from the primary.During the primary another company's cup and liner were used.The pathogen will not become available.The surgeon washed out the hip and revised the medacta head.

• Brand Name: BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5
• Type of Device: CERAMIC BALL 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, 6874 ; SZ 6874
• MDR Report Key: 7269585
• MDR Text Key: 100007198
• Report Number: 3005180920-2018-00042
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

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: 10/25/2021
• Device Catalogue Number: 01.29.201
• Device Lot Number: 164973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• 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