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

Model Number	01.12.026
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 february 2020.Lot 072499: 48 items manufactured and released on 26-nov-2007.Expiration date: 2012-09-30.No anomalies found related to the problem.To date, 46 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: femoral component revision performed 11 years after primary cementless total hip arthroplasty in (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.Partial radiographic images provided don't allow a proper clinical investigation.However, radiolucent lines are visible aseptic loosening is a possible literature described long-term adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery of quadra size 6 std stem for pain 10 years and 11 months after the primary.Radiolucent lines are visible in proximal medial and lateral section of the femur and anterior and posterior section on axial xray, aseptic loosening may be present.The stem was distally stable but had to be removed due to complaint of pain from the patient.The stem was successfully removed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9750251
• Report Number: 3005180920-2020-00109
• Device Sequence Number: 1767105
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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 Expiration Date: 09/30/2012
• Device Model Number: 01.12.026
• Device Catalogue Number: 01.12.026
• Device Lot Number: 072499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/25/2020
• 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: 66 YR