MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4; HIP CEMENTLESS STEM

Model Number	01.13.104R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-january-2022: lot 188026: (b)(4) items manufactured and released on13-feb-2019.Expiration date: 2024-01-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: fracture of the femoral stem in cementless tha 2 years after primary surgery and 1.5 years after a first revision surgery during which a lengthening retroverted modular head has been implanted.According to report, this was done to correct suboptimal position of the femoral stem that presented excessive anteversion with subsequent recurrent dislocation.This suboptimal position cannot be judged by the limited iconography supplied.Also, we do not know what led the primary stem to end up in a suboptimal position and if this was the immediate result of primary operation or of subsequent migration/displacement.The lengthening-retroverting sleeved head is not approved by medacta, manufacturer of the femoral stem, to be associated with it.The root cause of the fractured stem is with all likelihood to be sought in the use of an unapproved adaptor.
Event or Problem Description
Revision surgery was performed due to stem neck breakage.The primary surgery was performed on (b)(6) 2020.On (b)(6) 2020 the head, liner, and cup were revised due to joint dislocation.During the first revision surgery, the head put in was a merete bio ball with a long adapter.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT 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: 13384920
• Report Number: 3005180920-2022-00052
• Device Sequence Number: 11956906
• Product Code: LZO
• UDI-Device Identifier: 07630030803222
• UDI-Public: 07630030803222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170845
• 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): 01/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 01.13.104R
• Device Catalogue Number: 01.13.104R
• Device Lot Number: 188026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2019
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White