MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3; CEMENTLESS HIP STEM

Model Number	01.18.173
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.November.2021.Lot 178487: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-03-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager.Femoral component revision performed 3 years and 5 months after primary total hip arthroplasty in a (b)(6) woman.No information concerning patient general health status and the presence of comorbidities is available.In the low quality radiographic images provided, some 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 3 years and 5 months after the primary surgery, revision surgery was performed due to stem mobilization.

• Brand Name: STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• 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: 13073517
• Report Number: 3005180920-2021-00996
• Device Sequence Number: 12264699
• Product Code: LZO
• UDI-Device Identifier: 07630030804380
• UDI-Public: 07630030804380
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 03/15/2023
• Device Model Number: 01.18.173
• Device Catalogue Number: 01.18.173
• Device Lot Number: 178487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2018
• 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: 65 YR
• Patient Sex: Female