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

Model Number	01.36.047
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery on bilateral patient at about 1 year 7 months after the primary due to aseptic insufficient osteointegration of the sms solid stem.No infection detected.
Additional Manufacturer Narrative
Batch review performed on 16 december 2023: lot 2003752: (b)(4) items manufactured and released on 08-june-2020.Expiration date: 2025-05-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by medacta r&d hip project manager: during the analysis it is evaluated that the stem is still covered with porous coating.It is not possible to determine the root cause of incorrect osteointegration and asepting loosening.Clinical evaluation performed by medacta medical manager: revision surgery 1 year and 6 months after primary cementless tha due to painful conditions possibly related to an undersized stem.No infection detected but, according to report, undetected low grade infection has not been excluded.Additionally, the surgeon had difficulty to remove the stem and from the pictures of the stem it is visible bone attachment on the extracted stem.

• Brand Name: SMS SOLID STEM STD 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16322734
• Report Number: 3005180920-2023-00033
• Device Sequence Number: 8583719
• Product Code: LZO
• UDI-Device Identifier: 07630030888663
• UDI-Public: 07630030888663
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 02/08/2023

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 Expiration Date: 05/27/2025
• Device Model Number: 01.36.047
• Device Catalogue Number: 01.36.047
• Device Lot Number: 2003752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White