MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; CEMENTLESS STEM

Model Number	01.12.025
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year 9 months after the primary, the patient came in reporting pain due to a loose stem and suspected impingement.The surgeon revised the stem (quadra-h to quadra r), head, and liner.
Additional Manufacturer Narrative
Batch review performed on 15 march 2022.Lot 1906324: (b)(4) items manufactured and released on 17-oct-2019.Expiration date: 2024-10-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: less than 2 years after primary cementless tha in a rather young man, the stem is painful and loose and needs replacing.The radiographs show a loose stem and a cup that could have been placed more medial: the actual position may cause impingement between stem and cup or between cup and soft tissues, inducing undue stresses on the stem.This could be the main cause for stem loosening, but of course the information at hand is not sufficient to draw a firm conclusion.We see no reason to suspect a faulty device.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 13803788
• Report Number: 3005180920-2022-00186
• Device Sequence Number: 4104875
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 10/06/2024
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 1906324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2019
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White