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

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 092436: (b)(4) items manufactured and released on 11-dec-2009.Expiration date: 2014-10-31.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.Clinical evaluation performed by medical affairs manager: acetabular component revision occurred about 9 years after cementless double mobility total hip arthroplasty.No information concerning patient age and general health status is available.Initial position of the component cannot be assessed on the basis of the single pre-revision x-ray provided.Aseptic loosening is a possible literature described long term adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
About 9 years after primary the surgeon revised the patient hip for cup loosening.Cup, head and liner swap.The surgery was performed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8503597
• Report Number: 3005180920-2019-00268
• Device Sequence Number: 13933271
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 10/31/2014
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 092436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/11/2019
• 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