MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52; ACETABULAR CUP CEMENTLESS

Model Number	01.26.52MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 4 years 9 months after the primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup and liner to competitors and revised the medacta head to a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 december 2022.Lot 160830: (b)(4) items manufactured and released on 20-may-2016.Expiration date: 2021-may-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52
• Common Device Name: ACETABULAR CUP CEMENTLESS
• 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: 13469122
• Report Number: 3005180920-2022-00068
• Device Sequence Number: 17451332
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 05/09/2021
• Device Model Number: 01.26.52MB
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 160830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2016
• 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: Male