MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 1 R; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.07.2401R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02-jul-2021.Lot 082446d: 1 item manufactured and released on 12-mar-2019.Expiration date: 2024-02-27.No anomalies found related to the problem.Additional item involved in the mix-up: gmk-primary 02.07.2104r femur ps cementless size 4 r lot.082864a.Batch review performed on 02-jul-2021.Lot 082864a: 1 item manufactured and released on 13-mar-2019.Expiration date: 2024-02-27.No anomalies found related to the problem.Preliminary investigation: the mix-up has been confirmed, a box labeled with the ref.(b)(4), lot 082864a, (gmk primary cementless femur size 4 right) was found to include ref.02.07.2401r, lot 082446 (gmk revision ps femur size 1 right) and viceversa.A recall of the lot 082446d was necessary to confirm the mix-up and we have found the size 4 right - lot 082864a of gmk primary cementless - in the box labeled with the lot 082446d.Letters a and d are present at the end of the lot because they are assigned in the re-sterilization process of lots, as per medacta international internal procedure.Both lots involved in the action are composed of 1 device each.Country involved in the recall: (b)(6).
Event or Problem Description
During the surgery, opening the gmk-primary femur size 4 box it was found a gmk-revision size 1 item.The surgery was completed successfully using a size 4 gmk-primary narrow implant as a back-up.
Additional Manufacturer Narrative
After device receival on (b)(6) 2021 the mix-up has been confirmed, a box labeled with the ref.(b)(4), lot 082864a, (gmk primary cementless femur size 4 right) was found to include ref.(b)(4), lot 082446 (gmk revision ps femur size 1 right).

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 1 R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12141654
• Report Number: 3005180920-2021-00573
• Device Sequence Number: 17360535
• Product Code: JWH
• UDI-Device Identifier: 07630030821370
• UDI-Public: 07630030821370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: 02.07.2401R
• Device Catalogue Number: 02.07.2401R
• Device Lot Number: 082446D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other