MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 46; HIP METAL CUP

Catalog Number	01.26.46MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-dec-2019.Lot 162195: (b)(4) items manufactured and released on 30-jun-2016.Expiration date: 16.06.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta r&d hip project manager: from preliminary visual it is not possible to analyze explanted components and determine failure root cause.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 2 years after cementless double mobility total hip arthroplasty due to pain.The cause of pain may be impingement of the components probably due to suboptimal cup position.The reason of this position may be related to pelvis bone morphology that didn't allow a deeper preparation of the acetabulum.
Event or Problem Description
Revision surgery performed due to pain and impingement 2 years after primary.The shell was anteverted, no metallosis has been seen.The shell came out relatively easily, a 50 mm g7 with dm liner and bearing were implanted and we put in +4 sleeve with 28mm ceramic biolox option.Impingement was confirmed intraoperatively and there were some marks on the neck of the femoral component that was left in place.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 46
• Common Device Name: HIP METAL CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9481017
• Report Number: 3005180920-2019-01052
• Device Sequence Number: 399735
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 06/16/2021
• Device Catalogue Number: 01.26.46MB
• Device Lot Number: 162195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/17/2019
• 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