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

Model Number	01.12.024
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 8 may 2020 lot 134610: (b)(4) items manufactured and released on 20-nov-2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs manager: femoral stem, head and standard polyethylene liner revision occurred 6 years after primary total hip arthroplasty.According to the report, the patient was complaining about pain.Areas of reduced bone density around the stem are visible in the radiographic image provided osteolysis may be the consequence of polyethylene wear that is commonly seen and described in literature, however wear was not measured in this case and therefore correlation is not established.
Event or Problem Description
Aseptic loosening of a quadra h stem after 6 years and 2 months from the primary.The stem, head and insert were changed.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10086354
• Report Number: 3005180920-2020-00290
• Device Sequence Number: 2561841
• Product Code: LZO
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2014
• 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): 05/26/2020

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: 10/31/2018
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 134610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/26/2020
• 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: 78 YR