MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø46

Catalog Number 01.32.146MB

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 13 may 2019 lot 160424: (b)(4) items manufactured and released on 10-mar-2016.Expiration date: 2021-03-08.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.Manufacturing process review: event notified to coating manufacturer on the 26 april 2019.On the (b)(6) 2019 the coating supplier reported as follow about this complaint: this episode is similar to other reported in 2018 and, in every cases, pieces were made in 2016 or before.After previous complaints, a final check was added on pieces produced in vps in order to check if there is material loss from the device.In this case, the particles present in the package, can be due to the fact that device is smaller than blister dimension and the shell is free to move inside it with the consequence of more debris loss.Visual inspection performed by (b)(4): we confirm the presence of coating debris in the packaging.Actually, we perform a double check on the packaging as per (b)(4) in order to find impurity inside the blister and on the packaging welding.In this case the packaging was conform (no impurity).For this reason the debris inside the packaging detached during transportation and so is not possible to identify the issue before the implant expedition from medacta.

Event Description

During the primary hip surgery and upon opening the sterile packaging of the 46mm cup, it was discovered that there was foreign debris on the cup (piece of coating).The surgeon implanted a different 46mm cup and there was no delay in the case.The surgery was completed successfully.The agent stated the cup came out of a consignment set.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø46
• Type of Device: DOUBLE MOBILITY ACETABULAR SHELL
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 8612049
• MDR Text Key: 145768745
• Report Number: 3005180920-2019-00368
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860942
• UDI-Public: 07630030860942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• 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: 05/15/2019

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: 03/08/2021
• Device Catalogue Number: 01.32.146MB
• Device Lot Number: 160424
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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