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

Model Number	01.12.034
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years 5 months after the primary, revision surgery performed due to asepting stem loosening.The surgeon revised successfully stem, head and liner.
Additional Manufacturer Narrative
Batch review performed on 17 may 2023: lot 150213: (b)(4) items manufactured and released on 13-may-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision about 7 years 5 months after the primary total hip surgery due to asepting stem loosening in a 73 year old patient.The surgeon revised successfully stem, head and liner.From the radiographic image radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: HIP 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: 17105639
• Report Number: 3005180920-2023-00414
• Device Sequence Number: 12238977
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• 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: 2015
• Device Explanted Year: 2023
• 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): 06/12/2023

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: 03/31/2020
• Device Model Number: 01.12.034
• Device Catalogue Number: 01.12.034
• Device Lot Number: 150213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2015
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic
• Patient Race: White