MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48; ACETABULAR CUP

Catalog Number	01.26.48MB
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 december 2019.Lot 165684: (b)(4) items manufactured and released on 25-jan-2017 expiration date: 01/10/2022.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 events.Additional implant involved: stem: minimax 01.13.102r cementless anatomical stem right size 2 (k170845) lot.172015.Batch review performed on 4 december 2019 lot 172015: (b)(4) items manufactured and released on 31-aug-2017 expiration date: 18/08/2022.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 events.Clinical evaluation performed by medical affairs manager hip revision surgery performed 1 year and 8 months after cementless double mobility total hip arthroplasty in a (b)(6) year old woman.Radiographic image provided shows suboptimal cup position.The reason of this choice is unknown: bone morphology or patient anatomy may be one reason but this cannot be confirmed on the basis of a single anteroposterior x-ray.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed 1 year and 9 months after the primary due to impingement (the cup with the stem or the lesser trochanter with the pelvis).The cup was anteverted (the cause is unknown).The surgeon revised the head and liner.Infection not present.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9525226
• Report Number: 3005180920-2019-01084
• Device Sequence Number: 16258278
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/27/2019

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: 01/10/2022
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 165684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2019
• Initial Report FDA Received Date: 12/27/2019
• 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
• Patient Age: 56 YR
• Patient Weight: 90