MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 54

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018.Lot 110040: (b)(4) items manufactured and released on 05 may 2011.Expiration date: 2016-03-31 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.Preliminary investigation performed on 10 april 2018 by r&d product manager: from the images available no conclusions can be drawn.On 13 april 2018 the medical affairs director made the following analysis: partial hip revision surgery (cup, liner and head) occurred 7 years after primary cementless total hip arthroplasty in an elderly lady.Radiographic images provided show the presence of a mobilized acetabular component.The primary position of the cup cannot be assessed as no immediate postoperative x-ray is available.According to the report, the surgeon suspects infection but no confirmation is available at the time of this clinical evaluation.The reason of this event cannot be determined on the basis of available information.
Event or Problem Description
Revision surgery performed to remove cup as it was loose and had moved about seven years from the primary.Surgeon suspected a loose cup due to its position and symptoms from patient.He also suspected infection and sent of tissue samples to confirm.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7428044
• Report Number: 3005180920-2018-00235
• Device Sequence Number: 19261896
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 03/31/2016
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 110040
• 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: 03/14/2018
• Initial Report FDA Received Date: 04/13/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 50