MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; CEMENTLESS STEM

Model Number 01.12.22SN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 3 july 2020: lot 165623: (b)(4) items manufactured and released on 15-nov-2016.Expiration date: 2021-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient was approximately 3 years of post-primary replacement (2017) came back to the surgeon with complaints of pain.The stem was found to be loose proximally but well fixed distally.The surgeon stated the patient had been water skiing on their replacement.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
• Type of Device: CEMENTLESS 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: 10288602
• MDR Text Key: 199558902
• Report Number: 3005180920-2020-00457
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/17/2020

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: 01/11/2021
• Device Model Number: 01.12.22SN
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 165623
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2016
• 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