MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 R

Catalog Number 02.09.2603R

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

We immediately investigated the case and determined that a mix-up between one component of each of these two lots happened during packaging.We inspected a unit from lot 173033 in stock and found the piece from lot 173034.With this, we had full control over the two mixed components.After this confirmation, the rest of both lots were inspected to confirm that the mix-up only involved one piece from each lot and all were conforming.Batch review performed on 13 september 2018.Lot 173034: (b)(4) items manufactured and released on 02 august 2017.Expiration date: 2022-07-04.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.Gmk-hinge femoral component size 5 l reference 02.09.2605l (k130299).Lot 173033: (b)(4) items manufactured and released on 02 august 2017.Expiration date: 2022-07-04 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.Visual inspection performed by packaging and washing manager on 14 september 2018 the pictures attached to the complaint and the returned piece confirmed that there was a mix up.From a documental control it was noticed that the two lots involved in this case were consequently processed.Interviewing the operator and checking the process it is possible suppose that the two lots were packaged in the same time in the cleaning room.Due to human error, there was a mix up a piece of the two lots.The event is related to an human error, in fact the procedure reports the operators must process lots one by one.

Event Description

During a surgery, the box of a gmk hinge femur size 3 right (code 02.09.2603r - lot 173034) was opened and a gmk hinge femur size 5 left (code 02.09.2605l - lot 173033) was found inside.The surgeon completed the surgery implanting a gmk-hinge femoral component size 4r given that a gmk-hinge femoral component size 3r back-up was not available.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 3 R
• Type of Device: FEMORAL COMPONENT
• 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: 7876585
• MDR Text Key: 120719110
• Report Number: 3005180920-2018-00681
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825446
• UDI-Public: 07630030825446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: 02.09.2603R
• Device Lot Number: 173034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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