MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

Catalog Number 01.29.209

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 december 2018.Lot 148661: 95 items manufactured and released on 11 march 2015.Expiration date: 2020-01-31 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of a leg length discrepancy, 2 years and 7 months after primary surgery.The surgeon revised the head and the surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
• Type of Device: CERAMIC BALL 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: 8202411
• MDR Text Key: 131593942
• Report Number: 3005180920-2018-01041
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809200
• UDI-Public: 07630030809200
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2018

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: 01/31/2020
• Device Catalogue Number: 01.29.209
• Device Lot Number: 148661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• 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