MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4; HIP UNCEMENTED STEM

Model Number 01.12.004

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15.Feb.2021: lot 083861: (b)(4) items manufactured and released on 3-feb-2009.Expiration date: 2013-12-31.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.

Event Description

Revision surgery 11 years and 8 months after the primary surgery for pain due to a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem, head, and liner and the surgery was completed successfully.

• Brand Name: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4
• Type of Device: HIP UNCEMENTED 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: 11331085
• MDR Text Key: 231962891
• Report Number: 3005180920-2021-00121
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030801853
• UDI-Public: 07630030801853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2021

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: 12/31/2013
• Device Model Number: 01.12.004
• Device Catalogue Number: 01.12.004
• Device Lot Number: 083861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2009
• 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