MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24.June.2021: lot 156273: (b)(4) items manufactured and released on 26-01-2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date,all items of this same lot have been sold without other similar reported events since 2017.Additional implant involved: gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3-i4 l (k121416) lot.152006.Batch review performed on 24.June.2021: lot 152006: (b)(4) items manufactured and released on 12-05-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events since 2017.Additional implant involved: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot.156095.Batch review performed on 24.June.2021: lot 156095: (b)(4) items manufactured and released on 29-02-2015.Expiration date: 2021-02-01.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events since 2017.
Event or Problem Description
Revision surgery performed about 5 years after the primary surgery due to low-grade infection.All implants were revised.The exact primary date is unknown.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12133386
• Report Number: 3005180920-2021-00568
• Device Sequence Number: 14403112
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 07/08/2021

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: 01/06/2021
• Device Model Number: 02.12.0004L
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 156273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• 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: Required Intervention