MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3; HIP FEMORAL STEM

Catalog Number	01.18.413
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-jun-2024.Lot 2214524: (b)(4) items manufactured and released on 04-nov-2022.Expiration date: 2027-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: late infection in cementless tha, 1.3 years after primary operation.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.Other devices involved: batch review performed on 27-jun-2024.Liner: mectacer 01.29.414 ceramic liner ø 36 / f (not distributed in us) lot.2217263 : (b)(4) items manufactured and released on 25-oct-2022.Expiration date: 2027-10-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2247815: (b)(4) items manufactured and released on 05-jan-2023.Expiration date: 2027-12-06.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 (k103352) lot 2240318: (b)(4) items manufactured and released on 05-jan-2023.Expiration date: 2027-12-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 1 year and 3 months after primary, the patient has been revised because of infection which caused stem loosening.No mobilization of the acetabular shell has been detected.The surgeon revised successfully all components and implanted a m-vizion stem with versafitcup dm components and ceramic ball head.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
• Common Device Name: HIP FEMORAL 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19790171
• Report Number: 3005180920-2024-00522
• Device Sequence Number: 11799502
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/19/2024

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 Catalogue Number: 01.18.413
• Device Lot Number: 2214524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 130 KG