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

Model Number	01.12.033
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2022 lot 1906983: lot 1906983: (b)(4) items manufactured and released on (b)(6) 2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed on (b)(6) 2022: revision at 2 years after tha due to pain and loosening.No information on the weight/age/activity of the patient are available.On the pre-revision x-ray we could see some apparently osteolytic regions, not explained.Often, osteolysis is the consequence of reaction to wear debris, but in this case no abnormal wear is visible and the time elapsed since index surgery is very limited.It is also possible that a local or systemic reaction to the implant materials took place, for unexplained reasons.On the lateral view, a hairline radiolucent mark is visible just below the stem, but it's probably non-consequential.The full explanation of the reasons of this adverse event is not possible with the information at hand.Preliminary investigation performed by r&d project manager on (b)(6) 2022: by looking at the images attached to the complaint it is visible the explanted stem with the body covered with patient blood.It seems that whole ha coating has been completely absorbed by patient bone, even if this evidence will be confirmed during the visual inspection is the stem will be available.Some signs and scratches are present on the neck part probably due to revision surgery.It is not possible to determine the root cause of reported patient pain before explantation.
Event or Problem Description
Revision surgery at about 2 years and 1 month from primary.The stem was fixed distally, signs of osteolysis were visible around the stem.The stem was revised and the surgery completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Common Device Name: HIP 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: 15156481
• Report Number: 3005180920-2022-00587
• Device Sequence Number: 5395344
• 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: 2020
• 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): 08/03/2022

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: 11/18/2024
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 1906983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2019
• 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 Sex: Unknown