MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P STD STEM SIZE 1; HIP FEMORAL STEM CEMENTLESS

Model Number	01.12.121
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-sep-2022.Lot 2010672: (b)(4) items manufactured and released on 27-jan-2021.Expiration date: 2026-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 6 months after the index tha in a overweight patient.The patient reported pain and according to report, the pain was due to lack of osteointegration.From the radiographic images, the position of the acetabular cup appears to be suboptimal.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.Additionally, the stem is undersized and in pronounced varus position which may be not of help given the high weight of the patient.In these conditions, primary stability may be severly challenged and osteointegration may become more unlikely.No reason to suspect faulty implants.Preliminary investigation performed by r&d department: looking at the images attached to the complaint it is visible that the explanted stem is covered with patient blood.It is not possible to evaluate if the coating has been absorbed by patient bone or not.Some signs and scratches are present on the neck surface probably due to revision surgery.It is not possible to determine the root cause of reported pain and incorrect osteointegration.
Event or Problem Description
At about 6 months after the primary surgery, the patient came in reporting hip pain probably due to lacking of osteointegration.Stem and head were revised and the surgery was completed successfully.

• Brand Name: STEM: QUADRA-P STD STEM SIZE 1
• Common Device Name: HIP FEMORAL STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15615073
• Report Number: 3005180920-2022-00772
• Device Sequence Number: 5911972
• Product Code: LZO
• UDI-Device Identifier: 07630040720427
• UDI-Public: 07630040720427
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/17/2022

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: 01/18/2026
• Device Model Number: 01.12.121
• Device Catalogue Number: 01.12.121
• Device Lot Number: 2010672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White