MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50; CEMENTLESS ACETABULAR CUP

Model Number	01.26.50MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 december 2021: lot 123980: (b)(4) items manufactured and released on 08-jan-2013.Expiration date: 2017-11-30.No anomalies found related to the problem.To date all the items of the same lot have been sold without any similar reported event since 01-jan-2017.Clinical evaluation performed by medical affairs director 8.5 years after primary cementless dm tha the patient feels groin pain and the surgeon decides to remove the cup.The stem is found well fixed and in good bone.The cup position looks slightly protruding laterally, perhaps because a large diameter cup was used, and this might be the source of the pain, but of course other factors may have determined the adverse reaction.As there is no radiographic history, it is also possible that the cup migrated from its original position: according to report, the cup was not really well integrated.The root cause for this adverse event cannot be determined with the information at hand.
Event or Problem Description
Revision surgery at 8 years and 7 months after primary surgery due to groin pain.During the revision it was recognized that the shell was loose.The surgeon revised successfully the shell, liner and head.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 50
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13076749
• Report Number: 3005180920-2021-01009
• Device Sequence Number: 5985112
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 11/30/2017
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 123980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female