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

Model Number	01.12.023
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 13 march 2020: lot 163265: (b)(4) items manufactured and released on 02-sep-2016.Expiration date: 2021-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) performed 3 years after cementless total hip arthroplasty in a (b)(6) year old farmer.Radiological images provided show the presence of radiolucent lines in gruen zones 1, 2, 6 and 7 and signs of stress shielding suggesting stem mobilization.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.Early return to high level of activities may reduce primary stability of the stem and hinder implant fixation.No conclusion can be drawn on the basis of available information.
Event or Problem Description
Revision surgery performed 3 years and 1 month after the primary surgery due to the proximal loosening of a quadra h stem.The surgeon revised the stem and ball head.The patient was a heavy working farmer.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9896985
• Report Number: 3005180920-2020-00203
• Device Sequence Number: 2225292
• 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: 2017
• 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): 03/30/2020

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: 08/18/2021
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 163265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/30/2020
• 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: 63 YR