MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER HEAD BIOLOX OPTION Ø 36; CERAMIC BALL HEAD

Catalog Number	01.29.232H
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2018.(b)(4).On 13 april 2018 the medical affairs director made the following analysis: according to report, the reasons for the third revision of this total hip is recurring dislocation.The information available does not allow a proper evaluation of the case and the determination of causes for loosening is not possible.We don't see any reason to suspect a faulty device.
Event or Problem Description
The sales representative has been informed by surgeon on 16 march 2018 that the patient came in complaining of hip pain.The surgeon plans to revise the hip on (b)(6) 2018.On (b)(6) 2018 the revision surgery was performed due to chronic dislocation 3 months after primary.The medacta head dislocated anteriorly from the competitor revision hooded liner that was cemented into competitor revision acetabular cup.

• Brand Name: MECTACER HEAD BIOLOX OPTION Ø 36
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7428043
• Report Number: 3005180920-2018-00236
• Device Sequence Number: 1963065
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: 01.29.232H
• Device Lot Number: 142132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68