MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14; CEMENTED HIP STEM

Catalog Number	01.12.041
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: hip revision surgery occurred 4 years and 8 months after implantation of a hybrid double-mobility total hip arthroplasty.No information concerning patient age, bmi and general health status is available.Both femoral (cemented) and acetabular (cementless) components were found to be loose, a rather unusual situation.Based on the information available, no final conclusion can be drawn.Batch review performed on 18 march 2019: lot 111149: 40 items manufactured and released on 29-apr-2011.Expiration date: 2016-03-31.No anomalies found related to the problem.To date, all the items of this lot have been already sold without any similar reported event.Additional implant involved in loosening: cup: versafitcup 01.26.50mb acetabular shell cc ø 50 (k083116) lot 135596: 60 items manufactured and released on 13-feb-2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, all the items of this lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2019 we were informed about a patient who came in complaining of pain 4 years and 8 months after the primary surgery due to an aseptic loosening of the stem and a loose cup.The cause of the loose cup is unknown.On the following day, the surgeon revised the cup, liner, head and stem and the surgery was completed successfully.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8436664
• Report Number: 3005180920-2019-00165
• Device Sequence Number: 13902159
• Product Code: LZO
• UDI-Device Identifier: 07630030802225
• UDI-Public: 07630030802225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 03/31/2016
• Device Catalogue Number: 01.12.041
• Device Lot Number: 111149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/20/2019
• 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