MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM LAT SIZE 11; CEMENTLESS HIP STEM

Model Number	01.36.071
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-sep-2020: lot 1905380: (b)(4) items manufactured and released on 28-aug-2019.Expiration date: 18-aug-2024.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medcal affairs director femoral stem loosening occurred in a young man ((b)(6) year-old).The stem had been placed after a traumatic fracture, treated with cerclage.It's very likely that the fracture did not heal completely or that the healing process compromised stem stability.The healing process can result in bone dimensional changes that may make the stem become undersized for the "new" femur.There is no reason to suspect a faulty device.
Event or Problem Description
4 months after the primary surgery, due to periprosthetic fracture which was caused from falling, the patient was revised.The surgeon cabled the fracture and revised the head, stem, and liner.Now, the patient came in reporting pain due to a loose femoral stem 7 months after the first revision surgery.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM LAT SIZE 11
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10572823
• Report Number: 3005180920-2020-00624
• Device Sequence Number: 19149947
• Product Code: LZO
• UDI-Device Identifier: 07630030888830
• UDI-Public: 07630030888830
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 09/23/2020

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: 08/18/2024
• Device Model Number: 01.36.071
• Device Catalogue Number: 01.36.071
• Device Lot Number: 1905380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/23/2020
• 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: 45 YR