MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2; HIP FEMORAL STEM

Catalog Number 01.13.102R

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/13/2024

Event Type  Injury  

Event Description

At 5 months from 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 stem and head and surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 18 march 2024 lot 1902970: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2
• Type of Device: 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: 19069662
• MDR Text Key: 339678347
• Report Number: 3005180920-2024-00190
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030803185
• UDI-Public: 07630030803185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.13.102R
• Device Lot Number: 1902970
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention