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

Model Number	01.26.45.0052
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 17.Mar.2021: lot 174453: (b)(4) items manufactured and released on 2-nov-2017.Expiration date: 2022-10-22.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Additional implant involved: stem: minimax 01.13.103r cementless anatomical stem right size 3 (k170845) lot.1810275.Batch review performed by medacta regulatory affairs department on 17.Mar.2021: lot 1810275: (b)(4) items manufactured and released on 11-apr-2019.Expiration date: 2024-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: after three years, the patient of this cementless tha suffers pain, which is probably caused by the progression of his lumbar lordosis which leads to impingement between stem neck and posterior edge of the cup.The cup is exchanged and repositioned.No reason to suspect a faulty device.
Event or Problem Description
The patient had pain and during the revision surgery, which was performed 2 years and 10 months after the primary surgery, stem neck-cup impingement and metallosis were noticed.The surgeon believes that a combination of the patient lumbar lordotic angle and the first revision surgery((b)(6) 2020 this patient had a stem and head revision due to stem mobilization) to a minimax stem with inbuilt anteversion, may have resulted in the posterior impingement (between the cup and the neck of the stem), and subsequent requirement for less anteversion on the cup.The surgeon revised the cup, liner and head.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11633015
• Report Number: 3005180920-2021-00279
• Device Sequence Number: 14339251
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/08/2021

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: 10/22/2022
• Device Model Number: 01.26.45.0052
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 174453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/08/2021
• 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: 37 YR
• Patient Weight: 120