MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE CEMENTED FEMUR

Model Number	02.12.0021R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 november 2023: lot 162674:(b)(4) items manufactured and released on 27-may-2016.Expiration date: 2021-05-02.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved: batch reviews performed on 14 november 2023.Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 18620: (b)(4) items manufactured and released on 26-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.12.0212fr tibial insert fixed sphere flex size 2/12 mm r (k121416) lot 186057: (b)(4)items manufactured and released on 26-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: a revision surgery was performed 4 years and 9 months after the implant of tka using cemented gmk sphere with a primary tibial stem.The reported cause of revision was loosening of the tibial and femoral component leading to knee instability and laxity.From the available x ray images, we can assess radiolucency lines around the tibial stem and a minimal anterior femoral notching.Aseptic loosening is a possible literature described adverse event after tka and causes are often unknown.In this case, the reason of the failure cannot be determined for sure, but we see no reason to think that the prosthetic implant was defective.
Event or Problem Description
Revision surgery due to knee instability and loosening of tibial and femoral components, at about 4 years 9 months from the primary.All components revised successfully to hinge system.
Additional Manufacturer Narrative
Follow up 1: d1 brand name corrected.D4 model number inserted in the correct field.The correct lot of the tibial tray (additional device involved) is 186207 and the batch has been modified.The batch of lot 186057 has been modified.Additional implants involved, batch review performed on 06 november 2024: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 186207: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 2023-11-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.12.0212fr tibial insert fixed sphere flex size 2/12 mm r (k121416) lot 186057: (b)(4) items manufactured and released on 27-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE CEMENTED 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18190074
• Report Number: 3005180920-2023-00911
• Device Sequence Number: 17777592
• Product Code: JWH
• UDI-Device Identifier: 07630030862458
• UDI-Public: 07630030862458
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 05/02/2021
• Device Model Number: 02.12.0021R
• Device Catalogue Number: 02.12.0021R
• Device Lot Number: 162674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2016
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White