MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD SIZE 5; FEMORAL STEM HA COATED CEMENTLESS

Model Number	01.18.135
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2021: lot 103205: (b)(4) items manufactured and released on 03-dec-2010.Expiration date: 2015-10-31.No anomalies found related to the problem.To date, all the items of this lot have been already sold without any similar reported event since 1-1-2017.Clinical evaluation performed by medacta medica affairs department: femoral component revision performed 10 years after primary cementless total hip arthroplasty in (b)(6) year old woman.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described long-term adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determine.
Event or Problem Description
Revision surgery 10 years after primary surgery due to the stem loosening.Stem and ceramic head were revised successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD SIZE 5
• Common Device Name: FEMORAL STEM HA COATED CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11313715
• Report Number: 3005180920-2021-00102
• Device Sequence Number: 3754145
• Product Code: LZO
• UDI-Device Identifier: 07630030804113
• UDI-Public: 07630030804113
• 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: 2011
• 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): 02/11/2021

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: 10/31/2015
• Device Model Number: 01.18.135
• Device Catalogue Number: 01.18.135
• Device Lot Number: 103205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 85