MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54; ACETABULAR SHELL CEMENTLESS

Catalog Number 01.26.45.0054

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 13 may 2019 lot 188631: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Instrument involved in the issue: amis 01.15.10.0263 amis cup impactor terminal-m10, lot 1755174: (b)(4) items manufactured and released on 25-jan-2018.No anomalies found related to the problem.To date, another similar event has been reported (complaint (b)(4)) visual inspection performed by r&d (b)(4): during the analysis it is evaluated that some scratches are present on the cup threaded hole and on the thread of the terminal.It is evaluable that the scratches caused the block of the cup inside the implant underlined in this complaint.

Event Description

When the surgeon introduced the cup into the acetabulum the thread of the terminal cup impactor broke out of the cup and damaged the thread of the cup.A new cup with the straight impactor was used to complete successfully the surgery.The thread breaks out when he was pushing the cup down to get the right anteversion.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Type of Device: ACETABULAR SHELL CEMENTLESS
• 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: 8612053
• MDR Text Key: 145768522
• Report Number: 3005180920-2019-00376
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2024
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 188631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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): Other