MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 3; UNCEMENTED HIP STEM

Catalog Number 01.12.033

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08-november-2019: lot 061366: 38 items manufactured and released on 18-october-2006.Expiration date: 2011-september-30.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 13 years after primary cemetless total hip arthroplasty in a (b)(6) man.The image provided doesn't allow a complete evaluation of the implant-bone interface: however, radiolucent lines are visible suggesting implant mobilization.No information concerning patient general health status is available.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 Description

Revision surgery performed, after 13 years from the primary surgery, due to stem loosening.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 3
• Type of Device: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9383327
• MDR Text Key: 168435405
• Report Number: 3005180920-2019-00990
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 01.12.033
• Device Lot Number: 061366
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR