MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46; CEMENTLESS CUP

Model Number	01.26.45.0046
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2020: lot 2001422: (b)(4) items manufactured and released on 04-june-2020.Expiration date: 2025-may-26.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.Clinical evaluation performed by medical affairs director: few weeks after cementless total hip arthroplasty, the surgeon decided to change the acetabular shell.In the radiographic image the cup shows excessive inclination (too horizontal).The reason of this position is unknown.We cannot tell if this was the primary position and, if so, the reasons of this choice as no preoperative or immediate postoperative x-ray is available.It is very likely that the cup never found its primary stability, perhaps because of insufficient press-fit or insufficient bone quality/bone preparation.
Event or Problem Description
2 months after primary surgery, the patient returned for revision surgery due to malpositioned cup, detected during routine surgery follow up visit.Amis revision approach was utilized, the cup was found to be well fixed but grossly malpositioned.Cup has been revised successfully, mpact revision cup used.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46
• Common Device Name: CEMENTLESS CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10949659
• Report Number: 3005180920-2020-00871
• Device Sequence Number: 2419310
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 05/26/2025
• Device Model Number: 01.26.45.0046
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 20001422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 12/04/2020
• 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: 70 YR
• Patient Weight: 75