MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2; HIP STEM CEMENTLESS

Model Number	01.12.032
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by hip r&d project manager.During the analysis it is evaluated that the ha coating is present on almost whole proximal half of the stem body.This means that the stem was not correctly osseointegrated.This is unexpected behaviour considering that the stem was implanted since 2016.The incorrect osseointegration is reasonable the root cause of reported stem loosening.Some scratches and signs are present on the neck surface probably due to revision surgery.It is not clearly evaluable the clinical cause of incorrect stem osseointegration.Batch review performed on 08-nov-2021.Lot 162983: (b)(4) items manufactured and released on 08-sep-2016.Expiration date: 2021-jul-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery was performed due to stem loosening 5 years after the primary surgery.The patient is very active, he performs a lot of running trails.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director femoral component (stem, head and liner) revision performed 5 years after primary cementless total hip arthroplasty in a young (55 year old at time of primary surgery) and active patient.In the radiographic image provided, 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: STEM QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: HIP STEM CEMENTLESS
• 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: 12779241
• Report Number: 3005180920-2021-00873
• Device Sequence Number: 4351165
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 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): 11/11/2021

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: 07/19/2021
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 162983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2016
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG