MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; HIP CEMENTLESS STEM

Model Number	01.12.22SN
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26.02.2021: lot 1904451: (b)(4) items manufactured and released on 4-sep-2019.Expiration date: 2025-10-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 3 months after cmentless total hip arthroplasty in a (b)(6) year old woman.No information concerning patient activity, general health status and presence of comorbidities.Radiographic images provided show stem subsidence and leg length discrepancy.The stem looks slightly undersized: the reason of this choice cannot be assessed on the basis of information received.The reason of this event cannot be determined.
Event or Problem Description
3 months after the primary surgery the stem subsided and it should have been revised but the surgeon could not extract it even after considerable effort.The stem remained in situ and a bigger head was implanted.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11504350
• Report Number: 3005180920-2021-00223
• Device Sequence Number: 2843973
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: 10/27/2025
• Device Model Number: 01.12.22SN
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 1904451
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/17/2021
• 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: 75 YR