MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

Catalog Number	01.26.45.0048
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018.Lot 166724: (b)(4) items manufactured and released on 28 february 2017.Expiration date: 2022-02-14 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.Other device involved: liner: cc e cc light flat pe hc liner ø 28 / c reference (b)(4) (k103352) lot 168647: (b)(4) items manufactured and released on 14 march 2017.Expiration date: 2022-02-27.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.Clinical evaluation performed by medical affairs manager on (b)(6) 2018 partial hip revision surgery (cup, head and liner) occurred 10 months after primary cementless total hip arthroplasty.The patient was complaining about instability.Radiographic images provided show suboptimal acetabular shell anteversion.The reason of this position may be due to patient anatomy or other factors that cannot be assessed on the basis of available information.
Event or Problem Description
The patient came in due to feeling unstable 10 months after primary surgery.The surgeon determined the cup was too anteverted.The surgeon revised the cup, liner and screw.The surgeon reamed to a 52mm.The surgery was completed successfully.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7572696
• Report Number: 3005180920-2018-00397
• Device Sequence Number: 16597771
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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: 05/14/2022
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 166724
• 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: 05/07/2018
• Initial Report FDA Received Date: 06/06/2018
• 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