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
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ACETABULAR SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8612053
• Report Number: 3005180920-2019-00376
• Device Sequence Number: 11262142
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/15/2019
• 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: Other