MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM

Model Number	01.12.027
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 august 2021: lot 083352/t: (b)(4) item manufactured and released on 02-feb-2012.Expiration date: 2016-dec-31.No anomalies found related to the problem.Original batch: lot 083352: (b)(4) items manufactured and released on 18-dec-2008.Expiration date: 2013-nov-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported events since 2017.
Event or Problem Description
The patient came in reporting pain.Revision surgery was performed 7 years and 10 months after the primary surgery due to stem mobilization.
Additional Manufacturer Narrative
Initial report sent on 20-sep-2021 without xrays analysis.This report was then filled to report also the aforementioned analysis.Clinical evaluation performed by medical affairs director 8 years after primary cmeentless tha the femoral stem gets painful and requires revision.No history of the case is available, only the pre-revision xrays.The devices look correctly positioned.Around the stem, in gruen zone 1, some lucency is visible: this can be due to progressive weakening of the femoral bone that made the strength of the bone-metal bond insufficient.It is also possible that the femoral canal, beside losing bone density, got progressively larger and the stem became too small for the new conditions.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12494937
• Report Number: 3005180920-2021-00758
• Device Sequence Number: 14219885
• Product Code: JDI
• UDI-Device Identifier: 07630030802089
• UDI-Public: 07630030802089
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 12/31/2016
• Device Model Number: 01.12.027
• Device Catalogue Number: 01.12.027
• Device Lot Number: 083352/T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 09/20/2021
• 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: 71 YR
• Patient Weight: 90