MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2; HIP CEMENTLESS ANATOMICAL STEM

Catalog Number	01.13.102R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2024.Lot 2201588: 10 items manufactured and released on 13-06-2022.Expiration date: 2027-05-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by (b)(4).Second revision 3 months after the first revision due to joint instability and stem mobilization.From the only image provided, the stem appears undersized and in a valgus position and for these reasons the surgeon decided to exchange it to a larger collared stem after restoring joint tension by changing the head.There is no reason to suspect a faulty device.Preliminary analysis performed by r&d project manager.Looking at the images attached to the complaint it is visible the explanted stem covered with patient blood.It is not possible to determine the root cause of reported failure from this image.
Event or Problem Description
Minimax stem mobilized and rotated in the patient's femur.Stem and head revised at about 3 months from the previous revision surgery.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2
• Common Device Name: HIP CEMENTLESS ANATOMICAL STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19719882
• Report Number: 3005180920-2024-00501
• Device Sequence Number: 20901571
• Product Code: LZO
• UDI-Device Identifier: 07630030803185
• UDI-Public: 07630030803185
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/11/2024

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 Catalogue Number: 01.13.102R
• Device Lot Number: 2201588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG