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

Model Number	01.18.134
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-aug-2022.Lot 121997: (b)(4) items manufactured and released on 11-jul-2012.Expiration date: 2017-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs manager: stem revision performed 9 years and 8 months after primary cementless total hip arthroplasty in a male patient.In the radiographic image provided, signs of stress shielding and radiolucent lines in gruen zones 1 and 7 are visible.As reported, for unknown reasons osseointegration failed to happen in this patient.The bone reacted trying to compensate for the lack of fixation but this resulted in untidy growth and eventually the stem got terminally loose.The reason of this failure cannot be determined.
Event or Problem Description
At about 9 years and 8 months after the primary, the patient came for a post-op appointment and it was observed that the stem never osseointegrated and the cause is unknown.The surgeon revised the stem, head, and liner and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15461311
• Report Number: 3005180920-2022-00722
• Device Sequence Number: 17224203
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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): 09/21/2022

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: 06/30/2017
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 121997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2012
• 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