MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; CEMENTLESS HIP STEM

Model Number	01.12.20SN
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2020: lot 189853: (b)(4) items manufactured and released on 11-feb-2019.Expiration date: 2024-01-09.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.Additional implant involved: ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 ø 36 size xl +8 (k112115) lot.177710.Batch review performed on 13 july 2020: lot 177710: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-13.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 medical affairs director: few months after primary cementless tha a revision is required due to subsidence of the femoral stem which caused a calcar fracture.We have only one radiographic projection available that shows a stem possibly undersized (difficult to judge from one projection).The patient seems to have got very small bones yet he is reported to be >(b)(6) kg; this combination is of course detrimental to the chances of stabilization for the cementless stem, as specified in the instructions for use.We could see no indication of a potentially defective device.
Event or Problem Description
The patient had a total hip replacement on the (b)(6) 2019.3 months after primary the patient was operated for calcar fracture and stem subsidende.The surgeon only fixed the fracture with cerclage.11 months after primary surgery the patient was operated again for pain (the reason of pain is unknown), the surgeon revised successfully the ceramic head and stem.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10319328
• Report Number: 3005180920-2020-00461
• Device Sequence Number: 3065579
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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: 2019
• 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): 07/24/2020

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: 01/09/2024
• Device Model Number: 01.12.20SN
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 189853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/24/2020
• 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: 69 YR