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

Catalog Number	01.18.133
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2024.Lot 102808: (b)(4) items manufactured and released on 01-oct-2010.Expiration date: 2015-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by (b)(4): revision 13 years and 4 months after primary tha due to stem loosening.The primary was done when the patient was 60 years old, so quite young.From the radiographic image signs of stress shielding are visible.Long term aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown, particularly in women after menopause.The reason of this failure cannot be determined.
Event or Problem Description
Revision due to stem loosening at about 13 years and 4 months post primary.Stem, head and liner revised successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 3
• Common Device Name: HIP FEMORAL 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19720351
• Report Number: 3005180920-2024-00502
• Device Sequence Number: 8290783
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• 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: 2010
• Device Explanted Year: 2024
• 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): 07/11/2024

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: 08/31/2015
• Device Catalogue Number: 01.18.133
• Device Lot Number: 102808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2010
• 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: 70 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White