MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING LAT STEM SIZE 2 12/14; CEMENTLESS STEM

Catalog Number 01.12.052

Device Problem Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/06/2024

Event Type  Injury  

Event Description

At 5 years and 10 months from the primary, revision surgery due to stem subsidence and consequent loosening.Stem, head and liner successfully revised with competitors implants.

Manufacturer Narrative

Batch review performed on 11 march 2024: lot 170904: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-27.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-C CEMENTED, MIRROR POLISHING LAT STEM SIZE 2 12/14
• Type of Device: CEMENTLESS 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19040598
• MDR Text Key: 339365429
• Report Number: 3005180920-2024-00164
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030802317
• UDI-Public: 07630030802317
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083558
• 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: 04/04/2024

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: 03/27/2022
• Device Catalogue Number: 01.12.052
• Device Lot Number: 170904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2017
• 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: 72 YR
• Patient Sex: Female