MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD SIZE 6; CEMENTLES FEMORAL STEM

Model Number	01.18.136
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-mar-2021: lot 161935: (b)(4) items manufactured and released on 17-jun-2016.Expiration date: 2021-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.Preliminary investigation performed by medacta r&d department: looking at the images attached to the complaint is clearly visible how the whole ha coating of the stem body has been absorbed by the patient bone as expected.No particular signs or scratches are visible on the stem body.The root cause of reported aseptic losening remains unknown.Clinical evaluation performed by medacta medical affairs department: femoral component revision performed 3 years and 4 months after primary cementless total hip arthroplasty.No information concerning patient age, general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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
Revision surgery performed due to stem loosening, 3 years and 4 months after the primary surgery.

• Brand Name: STEM: AMISTEM H HA COATED STD SIZE 6
• Common Device Name: CEMENTLES FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11568359
• Report Number: 3005180920-2021-00231
• Device Sequence Number: 3599294
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/25/2021

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: 06/05/2021
• Device Model Number: 01.18.136
• Device Catalogue Number: 01.18.136
• Device Lot Number: 161935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• 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