MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52; CEMENTLESS ACETABULAR CUP

Model Number	01.26.45.1152
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 september 2021.Lot 2001436: 100 items manufactured and released on 17-june-2020.Expiration date: 2025-06-01.No anomalies found related to the problem.To date, 87 items of the same lot have been sold without any similar reported event.
Event or Problem Description
Luxation due to too much anteversion of the cup.Head and liner successfully revised 2 months after the primary surgery.
Additional Manufacturer Narrative
Xrays analysis performed on (b)(6) 2021 clinical evaluation performed by medical affairs director few weeks after primary tha dislocation occurs and the surgeon decided to reposition the cup, which was probably had excessive anteversion for this specific patient.This adverse event was not caused by a device deficiency.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52
• 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: 12512821
• Report Number: 3005180920-2021-00755
• Device Sequence Number: 13728338
• Product Code: LZO
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 06/01/2025
• Device Model Number: 01.26.45.1152
• Device Catalogue Number: 01.26.45.1152
• Device Lot Number: 2001436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2020
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White