MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO SHELL Ø 52; CEMENTLESS ACETABULAR CUP

Catalog Number	01.26.45.0052
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 13 dec 17 the medical affairs made the following analysis: acetabular wall fracture occurred few days after surgery.Immediate postoperative fractures may be cused by intraoperative bone weakening due to acetabular preparation but also bone morphology and mechanical properties may have contributed.The initial position of the acetabular component cannot be assessed having no pre-fracture x-rays.In this case there is no reason to suspect a faulty device.Batch review performed on 14 december 2017.Lot 172504: (b)(4) items manufactured and released on 05 sept 2017.Expiration date: 2022-08-27 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.On the 15th of december the r&d project manager analysed the images received: from the images received no conclusion can be drawn.The event seems to be not implant related.
Event or Problem Description
Revision surgery performed, due to acetabular wall fracture, 6 days after primary surgery.The fracture of the acetabular wall occurred during the primary.The surgeon revised the cup, head liner and screws.

• Brand Name: VERSAFITCUP CC TRIO SHELL Ø 52
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7121398
• Report Number: 3005180920-2017-00751
• Device Sequence Number: 11179882
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 12/15/2017

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: 08/27/2022
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 172504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• 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