MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø40/G; FLAT PE LINER

Catalog Number	01.32.4052HCT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 september 2018.Lot 165678: 22 items manufactured and released on 21 october 2016.Expiration date: 2021-10-06.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any similar reported event.Biolox delta ceramic ball head 12/14 ø 40 size l + 4.Lot 167044 : 30 items manufactured and released on 20 march 2017.Expiration date: 2022-03-07 no anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.The supplier of the ball head has been informed about the issue on 31 august 2018 on 05 september 2018 they replied: protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ball head were according to the specification at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Clinical evaluation performed on 18 september 2018 by medical affairs director early dislocation in primary cementless tha, few days after surgery.Further surgery required but not executed for other medical reasons.From the one image supplied, we are unable to determine the cause for dislocation, there is no evident malposition of the components.However, there is no clue that the cause for dislocation could be attributed to a defective device.
Event or Problem Description
We were informed on (b)(6) 2018 that a revision surgery to be planned due to head dislocation from liner and cup happened 1 month after primary.Update 22 august 2018: the date in which the revision will take place is unknown.The patient was in cardiac distress and was unable to undergo surgery.

• Brand Name: MPACT FLAT PE HC LINER Ø40/G
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7888904
• Report Number: 3005180920-2018-00696
• Device Sequence Number: 2726224
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 10/06/2021
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 165678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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