MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED HIP STEM

Catalog Number 01.18.152

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 12 march 2019: lot 185891: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-25.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.Preliminary investigation performed by washing and packaging manager: based on the pictures received and the breakage experienced we can infer that there were extreme handling conditions that involved the packaging breakage.

Event Description

During surgery the second blister of the stem was found broke, a part of the stem was out of the packaging.A new stem was used to complete the case.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Type of Device: CEMENTED 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8416471
• MDR Text Key: 139074794
• Report Number: 3005180920-2019-00150
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103189
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2023
• Device Catalogue Number: 01.18.152
• Device Lot Number: 185891
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2018
• 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): Other