MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3; HIP STEM

Model Number	01.18.413
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 days after the primary surgery, the surgeon wanted to revise the patient because he was not satisfied by the way he initially implanted implants during the primary.The surgeon revised all components and the surgery was completed successfully.No issues were detected with the implants.
Additional Manufacturer Narrative
Batch review performed on 06-jun-2023 lot 2010561: (b)(4) items manufactured and released on 03-feb-2021.Expiration date: 2026-01-24.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.Other devices involved: liner: mpact dm 01.26.2858mhc double mobility hc liner 28/dmi (k092265) lot 2242684: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 2027-11-06.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.Ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot 173284b: (b)(4) items reworked and released on 18-jan-2023.Expiration date: 2027-12-27.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.Cup: mpact 01.32.158mb double mobility acetabular shell ø58 (k143453) lot 2111695: (b)(4) items manufactured and released on 21-mar-2022.Expiration date: 2027-03-02.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.

• Brand Name: STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3
• Common Device Name: HIP 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: 17077538
• Report Number: 3005180920-2023-00421
• Device Sequence Number: 2250774
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/07/2023

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: 01/24/2026
• Device Model Number: 01.18.413
• Device Catalogue Number: 01.18.413
• Device Lot Number: 2010561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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: Male