MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.142 HA COATED LAT STEM SIZE 2; FEMORAL COMPONENT

Model Number	01.18.142
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13.08.2021: lot 133081: (b)(4) items manufactured and released on 7-10-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event since 2017.
Event or Problem Description
7 years and 3 months after the primary surgery the surgeon revised the stem due to periprosthetic loosening of the stem (only stem was revised).
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Stem revision performed 7 years after primary cementless total hip arthroplasty.No information concerning patient age and general health status is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.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.On 20 october 2021 we received the information that the device is not available.

• Brand Name: STEM: AMISTEM H 01.18.142 HA COATED LAT STEM SIZE 2
• 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: 12452038
• Report Number: 3005180920-2021-00717
• Device Sequence Number: 17124666
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 08/31/2018
• Device Model Number: 01.18.142
• Device Catalogue Number: 01.18.142
• Device Lot Number: 133081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2013
• 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 Sex: Male
• Patient Weight: 85 KG