MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED SIZE 1; HIP STEM CEMENTED

Catalog Number 01.18.101

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

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

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 27 february 2019: lot 157360: (b)(4) items manufactured and released on 26-jan-2016.Expiration date: 2021-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by 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 outer blister was checked and no holes/ defect were found, while the second blister was found broken and a part of the stem was out of the blister.The surgery was completed with another stem.

Manufacturer Narrative

Visual inspection performed by washing and packaging manager: based on the pictures and the item received and considering the breakage experienced we can infer that there were extreme handling conditions that involved the packaging breakage.

• Brand Name: STEM: AMISTEM C CEMENTED SIZE 1
• Type of Device: HIP STEM CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8381780
• MDR Text Key: 139073907
• Report Number: 3005180920-2019-00115
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030803796
• UDI-Public: 07630030803796
• Combination Product (y/n): N
• PMA/PMN Number: K103189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Catalogue Number: 01.18.101
• Device Lot Number: 157360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other