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

Model Number	01.12.032
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2020: lot: 072508: 44 items manufactured and released on 30-oct-2007.Expiration date: 2012-09-30.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 component (stem, head and liner) revision performed 11 years and 10 months after primary cementless total hip arthroplasty in 72 year old woman.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described long-term adverse event after primary cementless hip arthroplasties, and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by medacta r&d hip project manager: from the received photos there are no suspects of failure device, as no particular signs on the device were noticed.Anyway, the reason of the event remains unknown.
Event or Problem Description
Loosening of a quadra-h stem implanted in 2009.Stem, head and liner have been successfully revised (11 years and 10 months after primary surgery).Revision was done with a minimax.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11045454
• Report Number: 3005180920-2020-00908
• Device Sequence Number: 19506184
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2009
• Device Explanted Year: 2020
• 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): 12/21/2020

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: 09/30/2012
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 072508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/21/2020
• 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: 72 YR
• Patient Weight: 88