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

Model Number	02.12.0023R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2020: lot 187175: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved in the event: gmk-sphere 02.12.0314fr tibial insert fixed sphere flex #3/14 mm r lot.186067 (k121416) batch review performed on 26 august 2020: lot 186067: (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.1203r tibial tray fixed cemented # 3 r lot.1810468 (k090988).Batch review performed on 26 august 2020: lot 1810468: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.0033rp patella resurfacing # 1 lot.1900599 (k090988).Batch review performed on 26 august 2020: lot 1900599: (b)(4) items manufactured and released on 30-apr-2019.Expiration date: 2024-04-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.F11030 primary extension stem ø11mm / l 30 mm lot.188116 (k133630).Batch review performed on 26 august 2020: lot 188116: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.1 year after primary surgery the surgeon removed all component's and implanted a medacta femur and insert with antibiotic cement to act as a temporary spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10521605
• Report Number: 3005180920-2020-00605
• Device Sequence Number: 19596886
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 11/20/2023
• Device Model Number: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 187175
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/11/2020
• 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