MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; HIP STEM CEMENTLESS

Model Number	01.12.021
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-oct-2022: lot 156124: (b)(4) items manufactured and released on 09-feb-2016.Expiration date: 2021-jan-25.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.Visual inspection performed by r&d project manager: during the analysis it is evaluated that almost all ha coating on the stem body has been completely absorbed by patient bone as expected.Some fragments are present on the stem body.Some signs and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of aseptic stem loosening reported in this complaint.
Event or Problem Description
Revision surgery performed at about 6 years and 1 month from primary for stem loosening.Stem head and liner revised successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15679266
• Report Number: 3005180920-2022-00801
• Device Sequence Number: 17620166
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 2016
• Device Explanted Year: 2022
• 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): 10/27/2022

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: 01/25/2021
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.0210
• Device Lot Number: 156124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2016
• 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: 35 YR
• Patient Sex: Female