MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 7; HIP CEMENTLESS STEM

Catalog Number	01.36.067
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-jul-2023.Lot 2116618: (b)(4) manufactured and released on 13-apr-2022.Expiration date: 2027-03-30.No anomalies found related to the problem.To date, (b)(6) of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 6 months from the primary tha due to a loose stem.In the radiographic image provided, the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single lateral radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
At about 6 months from the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: SMS SOLID STEM LAT SIZE 7
• Common Device Name: HIP CEMENTLESS 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: 17489184
• Report Number: 3005180920-2023-00632
• Device Sequence Number: 12730668
• Product Code: LZO
• UDI-Device Identifier: 07630030888793
• UDI-Public: 07630030888793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• 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): 08/09/2023

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: 01.36.067
• Device Lot Number: 2116618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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: 67 YR
• Patient Sex: Male