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

Model Number	01.12.032
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 february 2021: lot 132672: (b)(4) items manufactured and released on 28-aug-2013.Expiration date: 2018-07-31.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 since 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem, head and liner) revision performed 7 years after primary cementless total hip arthroplasty.No information concerning patient age, 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 adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d project manager: analyzing the explanted stem images it is visible that almost the whole ha coating has been absorbed by the patient bone as expected.Some signs of scratches are present on the neck surface but is reasonably possible that they are a created during the revision surgery.Looking at the explanted liner is visible a hole on its surface, probably due to the revision surgery.It is not possible to hypothesize a defined root cause.
Event or Problem Description
Revision surgery performed 7 years and 2 months after the primary surgery due to aseptic loosening of the stem.The stem and ball head were revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11473643
• Report Number: 3005180920-2021-00195
• Device Sequence Number: 14372250
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/12/2021

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: 07/31/2018
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 132672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/12/2021
• 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