MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC FLAT PE LINER; FLAT PE ACETABULAR LINER

Catalog Number	01.26.3644HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional details received on 11 dec 2017: the patient had two luxations on (b)(6) 2017.From the examination made by the surgeon, no "criticity" related to the primary implants has been detected.Surgeons cannot give an explanation about the luxations; cup and stem remained in place, since they are well fixed, while the flat insert and the ceramic head have been replaced.With a hooded insert and another head.On 22 dec 2017 the medical affairs director made the following analysis: recurrent dislocation in cementless primary tha, reoperated after few weeks.The stem and cup are well fixed and therefore left in place, while the insert is replaced to a hooded one.The acetabular cup was implanted with very little anteversion, but the use of a hooded insert may solve the dislocation problem, probably helped by better tensioning of the soft tissues around the hip.No reason to suspect a malfunctioning device led to this adverse event.Batch review performed on 02 january 2018: (b)(4).On (b)(6) 2018 the r and d project manager checked the image of the explant commenting as following: from the explanted liner showed in the image it is not possible to determine the root cause of the event as it can be due to several factors not related to the device, as patient's anatomy or the situation of muscles and tendons.The choice of the surgeon to substitute the polyethylene component with a hooded version potentially prevents these types of risk.
Event or Problem Description
Revision surgery performed due to multiple hip luxation about one month and half after primary.Hooded liner implanted.

• Brand Name: VERSAFITCUP CC FLAT PE LINER
• Common Device Name: FLAT PE ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163364
• Report Number: 3005180920-2017-00812
• Device Sequence Number: 19304979
• Product Code: LZO
• UDI-Device Identifier: 07630030807671
• UDI-Public: 07630030807671
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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: 03/01/2022
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 168655
• 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: 12/06/2017
• Initial Report FDA Received Date: 01/04/2018
• 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 Age: 79 YR
• Patient Weight: 80