MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 0; HIP STEM

Model Number	01.18.140
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-oct-2022 lot 146331: (b)(4) items manufactured and released on 23-jan-2015.Expiration date: 2019-dec-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 6 years 9 months after the primary surgery in a 66 year old patient due to stem loosening.In the radiographic image provided, radiolucent lines and 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
Revision surgery performed at about at about 6 years 9 months after the primary surgery due to stem loosening.The surgery was completed successfully implanting a quadra-p cemented stem.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 0
• Common Device Name: HIP 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: 15691209
• Report Number: 3005180920-2022-00813
• Device Sequence Number: 7359983
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/28/2022

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: 12/31/2019
• Device Model Number: 01.18.140
• Device Catalogue Number: 01.18.140
• Device Lot Number: 146331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2015
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 85 KG