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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00164
• Device Sequence Number: 12601336
• Product Code: LZO
• UDI-Device Identifier: 07630030802317
• UDI-Public: 07630030802317
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2022
• Device Catalogue Number: 01.12.052
• Device Lot Number: 170904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female