MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 58; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.0058
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 november 2017.Lot 171698: (b)(4) items manufactured and released on 23 august 2017.Expiration date: 2022-08-15.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.
Event or Problem Description
The day after primary surgery the hip luxated: suspected issue with the ball head length.Two days after, a revision was needed and the reason for hip luxation was found to be a mobilized cup.The surgeon replaced the cup and the insert.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 58
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7018031
• Report Number: 3005180920-2017-00655
• Device Sequence Number: 19067394
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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: 08/15/2022
• Device Catalogue Number: 01.26.45.0058
• Device Lot Number: 171698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: 40 YR
• Patient Weight: 75