MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT; CEMENTED KNEE FEMUR

Model Number	02.07.2212L
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 september 2022: lot 160939: (b)(4) items manufactured and released on 18-mar-2016.Expiration date: 2021-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: 5 years after primary tka a revision is required.Thesurgeons assessed that the cause for revision is hypersensitivity of the patient to nickel.This tyope of reaction is described in literature and can be developed by the patient secondarily to the intervention, often for external causes.No reason to suspect a faulty device at the origin of this adverse event, nor any defect in the index treatment.Addiitonal item involved in the event, gmk-primary 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot.164909.Batch review performed on 26 september 2022: lot 164909: (b)(4) items manufactured and released on 04-nov-2016.Expiration date: 2021-10-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
Knee components loosening (tibial tray and femur) due to nickel allergy.Revision surgery performed at about 5 years and 4 months post primary.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT
• Common Device Name: CEMENTED KNEE FEMUR
• 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: 15603079
• Report Number: 3005180920-2022-00780
• Device Sequence Number: 2186753
• Product Code: JWH
• UDI-Device Identifier: 07630030820946
• UDI-Public: 07630030820946
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: 02.07.2212L
• Device Catalogue Number: 02.07.2212L
• Device Lot Number: 160939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female