MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48; UNCEMENTED HIP SHELL

Catalog Number	01.26.48MB
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 183932: (b)(4) items manufactured and released on 29-oct-2018.Expiration date: 2023-10-09.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 evaluation performed by medical affairs manager: acetabular component revision due to fracture occurred few weeks after cementless double-mobility total hip arthroplasty.No information concerning patient age, comorbidities and bone quality is available.Subclinical intraoperative fracture and/or bone weakening due to acetabular preparation may have contributed to the occurrence of this event.There is no reason to suspect a faulty device.
Event or Problem Description
The patient came in, 4 weeks after primary surgery, complaining of pain caused by a fractured acetabulum.The cause of the fracture is unknown.The surgeon repaired the fracture and revised the cup, the liner and the head.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Common Device Name: UNCEMENTED HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478386
• Report Number: 3005180920-2019-00223
• Device Sequence Number: 1651329
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• 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): 04/03/2019

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: 10/09/2023
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 183932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/03/2019
• 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