MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VESAFITCUP CC TRIO ACETABULAR SHELL Ø 46; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.0046
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 17 november 2017.Partial hip revision surgery (cup, head and liner) occurred 4 months after primary total hip arthroplasty in a (b)(6) year-old woman.Radiographic image provided shows a mobilized cup and a fractured acetabular wall.The immediate post-surgical position of the cup cannot be assessed as no x-ray is available.The reason of this failure cannot be determined.Batch review performed on 20 november 2017.Lot 143426: (b)(4) items manufactured and released on 22 july 2014.Expiration date: 2019-06-30.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
Patient returned to surgeon for a checked up and complained of pain.X-ray revealed a acetabulum fracture.Surgeon performed revision surgery on (b)(6) 2017.

• Brand Name: VESAFITCUP CC TRIO ACETABULAR SHELL Ø 46
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7086821
• Report Number: 3005180920-2017-00727
• Device Sequence Number: 13768098
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 06/30/2019
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 143426
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/06/2017
• 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: 56 YR