MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number	01.18.434
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-feb-2024: lot 2313712: (b)(4) items manufactured and released on 20-sep-2023.Expiration date: 2028-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved: batch reviews performed on 28-feb-2024: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 2335083: (b)(4) items manufactured and released on 18-aug-2023.Expiration date: 2028-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot 2237206: (b)(4) items manufactured and released on 05-jan-2023.Expiration date: 2027-12-11.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.Mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2114486: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 month after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised successfully all the components.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS 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: 18940302
• Report Number: 3005180920-2024-00133
• Device Sequence Number: 6826706
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 01.18.434
• Device Lot Number: 2313712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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 Sex: Female
• Patient Race: White