MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3; HIP CEMENTLESS, HA COATED STD STEM

Model Number	01.12.023
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022 lot 071435: 45 items manufactured and released on (b)(6) 2007.Expiration date: (b)(6) 2012.No anomalies found related to the problem.To date, 41 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision performed 14 years and 6 months after primary cementless total hip arthroplasty in 83 year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines 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.Preliminary investigation performed by r&d manager: looking at the images attached to the complaint it only the proximal part of the body and neck both anterior and posterior are visible.The stem is covered by patient blood but is seems that no ha residuals are present, additionally some signs and scratches are visible on the neck part probably due to revision surgery.It is not possible to determine the root cause of reported complaint.
Event or Problem Description
At about 14 years and 6 months after the primary surgery, the patient was revised due to aseptic loosening of the stem.The surgery was completed successfully by revising stem, head and liner.

• Brand Name: STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS, HA COATED STD 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16032296
• Report Number: 3005180920-2022-00957
• Device Sequence Number: 7184401
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 2008
• 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): 12/22/2022

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: 06/30/2012
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 071435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2007
• 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: 83 YR
• Patient Sex: Male