MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.26.45.0054
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary date on (b)(6) 2019.First revision surgery on (b)(6) 2019 and (b)(6) 2019 due to infection (enterococcus faecalis e acinetobacter), deep wound cleansing and change of head and liner.Presently, (b)(6) 2022, the patient was revised due to infection (enterococcus fecalis).All implants removed and spacer implanted.Ref and lot are not available at the moment.
Additional Manufacturer Narrative
No analysis could be performed since lot numbers are not available at the moment and devices are not yet returned for inspection.
Additional Manufacturer Narrative
Batch review performed on 25 april 2022: lot 186881: (b)(4) items manufactured and released on 15-nov-18.Expiration date: 2023-nov-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional devices involved: batch review performed on 25 april 2022: ball heads: cocr 01.25.033 cocr ball head 12/14 ø 36 size xl +7 (k080885) lot 1906113: (b)(4) items manufactured and released on 08-oct-2019.Expiration date: 2024-sep-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Cup: versafitcup cc trio 01.26.45.0054 acetabular shell cc trio ø 54 (k103352) lot 1901419: (b)(4)items manufactured and released on 10-may-2019.Expiration date: 2024-apr-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by clinical affairs specialist: late infection in cementless tha, 3 years after primary operation.This is a second revision which happened due to infection.The first revision was done after few days from the primary surgery also due to infection which was cured with deep wound cleansing and with the removal of the mobile parts of the prosthesis.In the second revision all implants were removed and a spacer was implanted.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.During the analysis it is evaluated both the expianted stem and cup.Looking at the stem it is visible that almost first half of the ha coating on the stem body is still present, meaning that the stem was not correctly osteointegrated with the patient bone.Additionally some signs and screatches are present on the neck surface probably due to revision surgery.Looking at the cup it is visible that almast all ha coating on the external surface is still present, meaning that the cup was not correctly osteointegrated with the patient bone.Some bone and bloods residuals are present on the cup surface.Additionally some signs and screatches are present on the internal part probably due to revision surgery.It is not possible to determine the root casue of reported patient infection.

• Brand Name: AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS 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: 14186627
• Report Number: 3005180920-2022-00285
• Device Sequence Number: 20167508
• Product Code: JDI
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022
• 2 Devices were Involved in the Event: 1 2

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: 11/05/2023
• Device Model Number: 01.26.45.0054
• Device Catalogue Number: 01.12.021
• Device Lot Number: 186881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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: Male
• Patient Weight: 116 KG
• Patient Race: White