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

Catalog Number	01.26.45.0056
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by medacta r&d department on 6 november 2019: preliminary investigation shows components covered with biological fluids.It is not possible to determine any implant-related failure root cause.Clinical evaluation: acetabular component revision performed 5 months after cementless total hip arthroplasty in a heavy ((b)(6)) (b)(6) man.Radiographic images provided shows a suboptimal position of the cup.Due to unknown reasons, it was not possible to restore the native center of rotation.Batch review performed on 31 october 2019: lot 186851: 100 items manufactured and released on 22-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, 87 items of the same lot have been already sold without any similar reported event.Other device involved in the event: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.188246 (k112115) batch review performed on 31 october 2019: lot 188246: 210 items manufactured and released on 30-jan-2019.Expiration date: 2024-01-16.No anomalies found related to the problem.To date, 194 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed 6 months after the primary due to abductor pain, weakness at exercise and increased leg length caused by malpositioning of the cup.The surgeon revised the cup, liner and ball head successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9374816
• Report Number: 3005180920-2019-00985
• Device Sequence Number: 3040249
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 11/12/2023
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 186851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 89