MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; HIP CEMENTLESS STEM

Model Number	01.12.033
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed after about 5 years due to stem mobilization.The patient already underwent revision surgery due to hip luxation in 2018 where a double mobility system was implanted.
Additional Manufacturer Narrative
Batch review performed on 08-jul-2022: lot 170188: 60 items manufactured and released on 04-aug-2017.Expiration date: 2022-07-19.No anomalies found related to the problem.To date, 58 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation: revision 5 years after tha in a 70 year old patient due to aseptic loosening.During this time a partial revision of the ancetabular implant was performed due to recurring luxation, possibly influenced by the varus position of the stem.There are no post operative radiographs that let us evaluate if this position was the result of the index operation (which is more likely because the stem looks undersized) or if it happened later.Now the stem has been revised.Only the operated side is visible in the image, therefore it is not possible to compare the stem position with the controlateral side.Radiographic image provided shows the presence of radiolucent lines in gruen zone 1 and signs of stress-shielding.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• 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: 15092008
• Report Number: 3005180920-2022-00565
• Device Sequence Number: 14656129
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• 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): 07/25/2022

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: 07/19/2022
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 170188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2017
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White