MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 32; CERAMIC FEMORAL HEAD

Catalog Number	01.29.231H
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: early revision in primary cementless tha due to soft tissue impingement and recurrent dislocation.These problems are likely related to a rather shallow acetabulum that makes cup positioning challenging.No reason to suspect a faulty device.Batch review performed on 01 april 2019: lot 177730: (b)(4) items manufactured and released on 18-apr-2018.Expiration date: 2023-04-04.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 component involved: liner: mpact 01.32.3244hct flat pe hc liner ø32/e (k103721), lot 186965: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-24.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 or Problem Description
The patient had a primary hip surgery on (b)(6) 2016.On (b)(6) 2019, the patient came in complaining of anterior hip pain caused by the impingement of the cup on soft tissue and the surgeon subsequently revised the cup, liner and head (complaint (b)(4); mdr 2019-00112).Presently, one month after the previous revision surgery, the patient came in complaining of pain caused by a dislocation of the head from the liner.The dislocation only occurs when the patient is at 90 degrees and the surgeon is still investigating what is causing the dislocation to occur.The surgeon revised the head and option sleeve and the surgery was completed successfully.A direct anterior approach was used in the primary surgery.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 32
• Common Device Name: CERAMIC FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8473640
• Report Number: 3005180920-2019-00229
• Device Sequence Number: 19201097
• Product Code: LZO
• UDI-Device Identifier: 07630030809330
• UDI-Public: 07630030809330
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2023
• Device Catalogue Number: 01.29.231H
• Device Lot Number: 177730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/02/2019
• 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