MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50

Catalog Number	01.26.45.0050
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018; lot 177282: (b)(4) items manufactured and released on 20 february 2018.Expiration date: 2023-02-09; 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 investigation performed by medical affairs (b)(4) on 18 may 2018; early cup mobilization in primary cementless tha, few days after index surgery.The initial reaming of the acetabulum led to a cavity probably excessively deep, leaving little thickness of the acetabular wall.This is probably not the main cause for cup mobilization, which should be more likely due to a defect in the achievement of proper press-fit, unless a traumatic event, not reported, led to the mobilization.There is no reason to suspect a faulty device.Visual inspection performed by r&d product manager on 24 may 2018; the acetabular shell does not show any particular anomaly after visual analysis.Implantation and explantation signs are visible on the component.
Event or Problem Description
The surgeon revised the patient about 10 days after primary for a cup mobilization.He believes the mobilization depends from the acetabulum preparation performed during the primary surgery.The surgeon revised successfully the patient joint.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540700
• Report Number: 3005180920-2018-00362
• Device Sequence Number: 1818124
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 02/09/2023
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 177282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• 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: 63 YR
• Patient Weight: 83