MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 2; CEMENTLESS STEM

Model Number	02.12.0314FL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2020: lot 135419: (b)(4) items manufactured and released on 3-feb-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, 47 items of the same lot have been already sold without any similar reported event since 2016.Clinical evaluation performed by medical affairs manager: femoral component revision performed 6 years and 7 months after primary cementless total hip arthroplasty in a (b)(6) year old heavy ((b)(6) kg) man.In the radiographic images 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 after 6 years and 8 months after the primary surgery on the right side due to stem loosening.The stem was revised to quadra c,.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10919035
• Report Number: 3005180920-2020-00844
• Device Sequence Number: 2644565
• Product Code: LZO
• UDI-Device Identifier: 07630030826412
• UDI-Public: 07630030826412
• 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: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 12/31/2018
• Device Model Number: 02.12.0314FL
• Device Catalogue Number: 01.18.132
• Device Lot Number: 135419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/30/2020
• 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: 58 YR
• Patient Weight: 95