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

Model Number	01.18.145
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 6 years and 5 months post primary for femur osteolysis.The surgeon revised successfully the stem.
Additional Manufacturer Narrative
Batch review performed on 19 april 2022: lot 152132: (b)(4) items manufactured and released on 20-aug-2015.Expiration date: 2020-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Clinical evaluation performed by clinical affairs specialist.At 6 years after primary cementless tha the stem is no longer well fixed proximally and the patient feels pain.The report mentions osteolysis but the quality of the images provided does not allow to confirm this finding.Aseptic loosening at medium term is a possible adverse event following tha described in literature.No definite conclusion can be defined with the information at hand.Preliminary investigation performed by r&d project manager.Looking at the images attached to this complaint it is visible that all ha on the stem body has been absorbed by patient bone.There are huge residuals of patient bloods on the stem body and neck parts.Some signs and scratches are visible on the neck surface probably due to revision surgery.It is not possible to determine the root cause of reported explantation.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 5
• 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: 14373283
• Report Number: 3005180920-2022-00355
• Device Sequence Number: 5653744
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• 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: 2015
• 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): 05/12/2022

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: 07/14/2020
• Device Model Number: 01.18.145
• Device Catalogue Number: 01.18.145
• Device Lot Number: 152132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2015
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White