MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Model Number	01.12.024
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2021: lot 162021: (b)(4) items manufactured and released on 20-jun-2016.Expiration date: 2021-06-08.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
Revision surgery performed 3 years 8 months after primary due to stem loosening.Stem and head successfully revised.
Additional Manufacturer Narrative
Visual inspection: during the analysis it is evaluated that the whole ha coating on the stem body has been correctly absorbed by patient bone.Only some fragments are present on the proximal part of the stem colse to the neck part.On the neck part some signs and scratches are present, probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP 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: 12759289
• Report Number: 3005180920-2021-00858
• Device Sequence Number: 14288525
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 162021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2016
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 107 KG