MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; CEMENTLESS HIP SHELL

Catalog Number 01.26.45.1150

Device Problem Component Missing (2306)

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

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on october 01, 2018: lot 181706: (b)(4) items manufactured and released on 30 may 2018.Expiration date: 2023-05-16.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by washing and packaging manager on sep 14, 2018: through the provided pictures evaluation and the received packaging inspection it could be confirmed that the carton box was empty (the double blister and the device itself were missing).The error occurred during the packaging activities, when for the involved batch of 120 implants, the operators prepared 121 carton boxes; it was caused by a wrong management of an anomaly occurred during the packaging process and that had requested a reworking step in the clean room.The operator prepared 120 carton boxes according to route card instructions, without noticing that one implant had been moved back to be reworked; then, after reworking, the item was re-added to the involved lot and the operator packed it as well, without re-counting the total amount of the prepared carton boxes.Due to this issue, the same operator had to re-print an additional label for that device box in order to complete the packaging step: he just reported it as an "anomaly" in the route card, without trying to understand the reason for the missing label and without counting the packed boxes for that lot.In conclusion, once the lot was received back from the sterilization process, the warehouse reported in the system that 120 items were returned and stocked, but actually the total amount of implant boxes received was 121pcs.

Event Description

During surgery, the surgical staff opened the packaging of the acetabular shell cc trio no-hole and discovered that no implant was inside the carton box, not even the sterile plastic blisters of the implant.Only the ifu of the implant were found inside the carton box.The surgery was completed successfully with a second cup of the same size available on the consignment stock.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Type of Device: CEMENTLESS HIP SHELL
• 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: 7929603
• MDR Text Key: 122658766
• Report Number: 3005180920-2018-00739
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122911
• 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: 10/03/2018

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: 05/16/2023
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 181706
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• 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