MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58; CEMENTLESS HIP SHELL

Catalog Number	01.26.45.0058
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: partial hip revision surgery (head, cup and liner) occurred 7 months after primary cementless total hip arthroplasty.Radiographic image provided shows acetabular component mobilization.Primary cup position cannot be assessed as no immediate postoperative x-ray is available.No conclusion can be drawn on the basis of information received.Batch review performed on 11 december 2018: lot 134533: (b)(4) items manufactured and released on 22-nov-2013.Expiration date: 2018-10-31.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
The patient came in due to instability 7 months after primary which was caused by the cup becoming loose inside of the acetabulum.The surgeon revised the head, cup and liner and the surgery was completed successfully.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8155037
• Report Number: 3005180920-2018-00997
• Device Sequence Number: 10829919
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 10/31/2018
• Device Catalogue Number: 01.26.45.0058
• Device Lot Number: 134533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• 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