MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4; FEMORAL COMPONENT

Model Number	01.18.134
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 november 2021: lot 135428: 100 items manufactured and released on 29-jan-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, 99 items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs manager: femoral component revision performed 7 years and 8 months after primary cementless total hip arthroplasty in a young woman ((b)(6) at time of implantation).No information concerning patient general health status and level of activity 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
At 7 years and 8 months after the primary surgery, the patient had revision surgery due to stem mobilization.

• Brand Name: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13078016
• Report Number: 3005180920-2021-00993
• Device Sequence Number: 5630063
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 12/23/2021

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: 12/31/2018
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 135428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2014
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 85 KG