MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0023L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2023: lot 1908855: (b)(4) items manufactured and released on 18-dec-2019.Expiration date: 2024-12-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional involved implants: batch review performed on 23 october 2023 on gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.1908619 lot 1908619: (b)(4) items manufactured and released on 06-apr-2020.Expiration date: 2025-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.Batch review performed on 23 october 2023 on gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot.1910163 lot 1910163: (b)(4) items manufactured and released on 23-jan-2020.Expiration date: 2024-12-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery for infection at about 3 years, 1 month and a half post primary, all components revised successfully.The pathogen is not available.
Additional Manufacturer Narrative
Pieces received on 16th of november 2023.Visual inspection performed by r&d project manager: revision surgery after 3 years of primary implantation of a gmk sphere implant due to infection.From visual inspection of the explanted components sent back for investigation, we can't notice any anomalies that could have played a role in the event.From visual inspection there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
• Common Device Name: KNEE CEMENTED 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18138173
• Report Number: 3005180920-2023-00879
• Device Sequence Number: 6420811
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 12/04/2024
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 1908855
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White