MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.021 CEMENTLESS, HA COATED STD STEM SIZE 1; HIP CEMENTLESS, HA COATED STD STEM

Model Number 01.12.021

Device Problem Failure to Osseointegrate (1863)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 january 2023: lot 082244: (b)(4) items manufactured and released on 08-oct-2008.Expiration date: 2013-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: revision 14 years and 2 months after tha due to stem and cup loosening.The surgeon revised all the implant successfully.From the radiographic image, radiolucent lines in green zones 1 and 7 are visible, additionally, the position of the acetabular cup appears to be inadequate.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this event cannot be determined.Visual inspection performed by r&d manager: from the received parts, no relevant or evident signs of loosening related to the device were noticed.From the received information, it is not possible to determine the root cause of the event but we do not have information to relate this event to a failure of device.The cup involved in the complaint is not distributed in us.

Event Description

Revision at about 14 years and 2 months post primary for stem and cup loosening.The surgeon revised all the implant successfully.

• Brand Name: STEM: QUADRA-H 01.12.021 CEMENTLESS, HA COATED STD STEM SIZE 1
• Type of Device: HIP CEMENTLESS, HA COATED STD STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16396224
• MDR Text Key: 309779937
• Report Number: 3005180920-2023-00067
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 082244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2008
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 66 KG