MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC TRIO 56

Model Number	01.26.45.0056
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 september 2020: lot 1907460: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-10-28.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 event.
Event or Problem Description
Primary surgery performed on the(b)(6) 2020.On the (b)(6) (4 months after primary) a hip revision surgery was performed on the left side following a cup tilting problem for unknown reason.Explantation of a versafitcup trio size 56 with mobile parts in ceramic.Reimplantation of a versafitcup size 58 (+ screw) with mobile parts in ceramic.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC TRIO 56
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10689828
• Report Number: 3005180920-2020-00712
• Device Sequence Number: 3899592
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 10/28/2024
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 1907460
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• 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: 81 YR
• Patient Weight: 110