MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 54; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2017: lot 031551: 29 items manufactured and released on 19 december 2003.Expiration date: 2008-12-31.No anomalies found related to the problem according to the specifications valid at the time of production.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Twelve years after primary surgery the surgeon detected a cup loosening and revised the patient swapping successfully all the joint implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2018: 12 years after primary uncemented double mobility tha a revision is necessary for loosening.The cup shown in the pre-revision xray is too large and too vertical, and the stem is probably becoming loose also because of bone remodelling.With such a vertical cup and a standard pe double-mobility liner particulate debris may also have played a role in femoral mobilization, although this is not cited in the report.The patient is probably now rather old and a cemented stem is a safe solution that should not carry any long-term problems.The new cup has been properly oriented and dimensioned.
Event or Problem Description
Twelve years after primary surgery the surgeon detected a cup loosening and revised the patient swapping successfully all the joint implants.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7032799
• Report Number: 3005180920-2017-00656
• Device Sequence Number: 11205011
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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: 12/31/2008
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 031551
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/15/2018
• 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: 80 YR
• Patient Weight: 62