MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.12.034
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
About 5 years and 1 month after primary surgery, head and stem were revised due to stem loosening.Signs of impingement are visible in the explanted stem.
Additional Manufacturer Narrative
Batch review performed on 15 july 2022 lot 162985: 50 items manufactured and released on 12-aug-2016.Expiration date: 2021-jul-21.No anomalies found related to the problem.To date, 44 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta clinical manager: revision performed 5 years after primary cementless total hip arthroplasty in 60 years old man due to aseptic loosening.No information concerning patient general health status and the presence of comorbidities is available however, it is specified that the patient is a heavy working farmer.The femoral prosthesis explanted shows an impingement sign on the neck which must have been caused from impingement of the stem with the cup.In the radiographic image provided, the pre-revision posiotion of the cup seems to be different from post operative.This may be due to the cup having shifted because of impingement or, more likely, to a secondary tilting of the cup (perhaps due to a traumatic or quasi-traumatic event) which brought it in a position that caused impingement.Radiolucent lines and signs of stress shielding are visible, most likely a consequence of the impingement between femoral neck and cup rim.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15154906
• Report Number: 3005180920-2022-00599
• Device Sequence Number: 20164434
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• 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: 2017
• Device Explanted Year: 2022
• 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): 03/08/2022

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: 07/21/2021
• Device Model Number: 01.12.034
• Device Catalogue Number: 01.12.034
• Device Lot Number: 162985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White