MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; HIP STEM CEMENTLESS

Catalog Number 01.12.20SN

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 09/30/2023

Event Type  Injury  

Event Description

At about 3 years and 2 months after primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised successfully the medacta head and stem with competitor components and revised the medacta liner with a medacta liner.

Manufacturer Narrative

Batch review performed on 03-oct-2023.Lot 178387: (b)(4) items manufactured and released on 03-apr-2018.Expiration date: 2023-03-22.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
• Type of Device: HIP STEM CEMENTLESS
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18011654
• MDR Text Key: 326618391
• Report Number: 3005180920-2023-00823
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082792
• 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: 10/26/2023

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: 04/03/2018
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 178387
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2018
• 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: 77 YR
• Patient Sex: Male