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

Model Number 01.26.45.0056

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 11/16/2021

Event Type  Injury  

Event Description

The primary surgery took place in 2020 (the exact date is unknown).Revision surgery performed on (b)(6) 2021 because of a low-grade infection and osteoporosis.All implants revised.

Manufacturer Narrative

Batch review performed on 23 november 2021.Lot 1901423: (b)(4).Expiration date: 2024-may-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Clinical evaluation: infection in cementless tha.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Another devices involved: batch review performed on 23 november 2021: liner: mectacer 01.29.414 ceramic liner ø 36 / f (not registered in usa) lot 1904667: (b)(4).Expiration date: 2024-aug-31.No anomalies found related to the problem.(b)(4).Stem: amistem p 01.18.415 amistem-p lat stem size 5 (k173794)lot 1904149: (b)(4).Expiration date: 2024-jul-24.No anomalies found related to the problem.(b)(4).Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 1903861: (b)(4).Expiration date: 2024-jul-17.No anomalies found related to the problem.(b)(4).

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
• Type of Device: ACETABULAR SHELL
• 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: 12998610
• MDR Text Key: 282222889
• Report Number: 3005180920-2021-00976
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2024
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 1901423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male