MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED STD STEM SIZE 4; HIP STEM CEMENTLESS

Catalog Number	01.18.434
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department revision surgery 4 days from the primary tha due to a dislocation of the implants on a heavy patient.From the radiographic images, it is visible that the cup position 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.In these conditions, it is very likely that part of the femoral stem may impinge with the acetabular rim and therefore dislocation occurs.The cause of dislocation should be defined as cup position.The cause for such cup position is unknown.Batch review performed on 22-aug-2023 lot 2248423: (b)(4) manufactured and released on 27-apr-2023.Expiration date: 2028-04-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Additional component involved: batch review performed on 22-aug-2023.Cup: mpact 01.32.160mh acetabular shell ø60 multi-hole (k132879) lot 2000242: (b)(4)manufactured and released on 28-may-2020.Expiration date: 2025-05-18.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At 4 days from the primary, the patient came in for a post-op appointment and it was observed from x-rays that the cup was left lateral and the neck cut was long as well as anteverted stem and anteverted cup.All of this led to a posterior impingement that caused luxation and required the revision of all components.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED STD STEM SIZE 4
• Common Device Name: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17681422
• Report Number: 3005180920-2023-00699
• Device Sequence Number: 2598549
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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: 01.18.434
• Device Lot Number: 2248423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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: Male
• Patient Weight: 129 KG
• Patient Race: Black Or African American