MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 4; CEMENTLESS HIP STEM

Model Number	01.36.044
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 february 2021: lot 1906300: (b)(4) items manufactured and released on 05-sept-2019.Expiration date: 2024-08-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d project manager: the implant was explanted due to the patient pain.The surgeon informed that the implant was removed easily.Looking at the image attached to the complaint it seems that the ha coating as been absorbed by the bone but due to the high present of residual blood is not easily to evaluate the real situation.It is not possible to determine the root cause.Clinical evaluation performed by medical affairs director: stem revision performed 1 year and 2 months after primary cementless total hip arthroplasty in a (b)(6) year old woman.No information concerning patient activity, general health status and presence of comorbidities is available.Given the very short time in situ and the ease of removal, it's possible that for some reasons the osteointegration process never started.Perhaps this was due to failure of the stem to find sufficient primary stability for lack or press fit, we have no information on patient's status during the 12 months of life of the tha.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery 1 year and 2 months after primary.The patient had a lot of pain and during the surgery the stem came out easily.Stem and head revised successfully.The surgeon thinks that the reason of revision is loosening of the stem.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM STD SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11421677
• Report Number: 3005180920-2021-00173
• Device Sequence Number: 2776223
• Product Code: LZO
• UDI-Device Identifier: 07630030888632
• UDI-Public: 07630030888632
• 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: 2019
• Device Explanted Year: 2021
• 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): 03/05/2021

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: 08/27/2024
• Device Model Number: 01.36.044
• Device Catalogue Number: 01.36.044
• Device Lot Number: 1906300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR