MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 6; HIP CEMENTLESS ANATOMICAL STEM

Model Number	01.13.106L
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 4 months after the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the medacta stem and head with a competitor stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 may 2023.Lot 2006521: (b)(4) items manufactured and released on 22-dec-2020.Expiration date: 2025-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 6
• Common Device Name: HIP CEMENTLESS ANATOMICAL 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: 17123885
• Report Number: 3005180920-2023-00419
• Device Sequence Number: 20454980
• Product Code: LZO
• UDI-Device Identifier: 07630030803253
• UDI-Public: 07630030803253
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/14/2023

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: 12/09/2025
• Device Model Number: 01.13.106L
• Device Catalogue Number: 01.13.106L
• Device Lot Number: 2006521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2020
• 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: 84 YR
• Patient Sex: Male