MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50; HIP ACETABULAR SHELL

Model Number	01.26.50MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 october 2022: lot 2110831: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery at about 2 weeks after primary for cup mobilization.The reason of mobilization is unknown.

• Brand Name: CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15690002
• Report Number: 3005180920-2022-00790
• Device Sequence Number: 15130188
• 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: 2022
• Device Explanted Year: 2022
• 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): 10/28/2022

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: 09/12/2026
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 2110831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2021
• 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