MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; UNCEMENTED HIP STEM

Model Number	01.12.026
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed 4 years after cementless total hip arthroplasty in a young man ((b)(6) year old).No information concerning patient general health status and presence of comorbidities is available.Radiographic images provided show the presence of radiolucent lines around the stem and signs of stress shielding.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
The patient has been complaining of leg pain for about 6 weeks.After an investigation with radiology and scintigraphy, it was decided to change the shaft to quadra r (4 years and 2 months after primary surgery).

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10860234
• Report Number: 3005180920-2020-00798
• Device Sequence Number: 17131031
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/18/2020

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 Model Number: 01.12.026
• Device Catalogue Number: 01.12.026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 84