MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED HA COATED STD STEM SIZE 3; HIP STEM CEMENTLESS

Catalog Number	01.18.233
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-dec-2023.Lot 151474: 78 items manufactured and released on 03-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, 77 items of the same lot have been sold with another similar reported case during the period of the review.Clinical evaluation performed by medical affairs department.Revision at about 8 years after the primary tha due to loose stem.From the radiographic images, the stem is visibly loose, looking at the substantial radiolucent lines.According to report, this is an aseptic loosening.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 about 8 years after the primary, the patient came in reporting pain due to aseptic loosening and the cause is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED HA COATED STD STEM SIZE 3
• Common Device Name: HIP STEM CEMENTLESS
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18516285
• Report Number: 3005180920-2023-01101
• Device Sequence Number: 7588111
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 01/16/2024

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: 06/30/2020
• Device Catalogue Number: 01.18.233
• Device Lot Number: 151474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2015
• 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