MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS FEMORAL STEM; FEMORAL CEMENTLESS STEM

Catalog Number 01.13.105L

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 january 2018: lot 142843: (b)(4) items manufactured and released on 31 july 2014.Expiration date: 2019-06-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

During the implant opening the primary packaging blister resulted scratched and broken.A back-up stem was opened.The second stem had the primary packaging blister scratched but not broken and the surgeon considered it safe for the patient.

• Brand Name: MINIMAX CEMENTLESS FEMORAL STEM
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7160287
• MDR Text Key: 96330461
• Report Number: 3005180920-2017-00806
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 01.13.105L
• Device Lot Number: 142843
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2014
• 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
• Patient Age: 64 YR
• Patient Weight: 70