MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L; TOTAL KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0007L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 152871: 48 items manufactured and released on 17-jun-2015.Expiration date: 2020-05-31.No anomalies found related to the problem.To date, 45 items of the same lot have been sold without any similar reported case during the period of review.Additional components involved: gmk-sphere 02.07.1206l tibial tray fixed cemented size 6 l (k090988) lot 142707: 14 items manufactured and released on 29-jul-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported case during the period of review.Gmk-sphere 02.12.0610fl tibial insert fixed sphere flex size 6/10 mm l (k121416) lot 147263: 25 items manufactured and released on 22-apr-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, 20 items of the same lot have been sold without any similar reported case during the period of review.Gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot 151413: 110 items manufactured and released on 10-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported case during the period of review.
Event or Problem Description
At about 6 years and 4 months after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L
• Common Device Name: TOTAL KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14839824
• Report Number: 3005180920-2022-00493
• Device Sequence Number: 2382227
• Product Code: JWH
• UDI-Device Identifier: 07630030825897
• UDI-Public: 07630030825897
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/28/2022

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: 05/31/2020
• Device Model Number: 02.12.0007L
• Device Catalogue Number: 02.12.0007L
• Device Lot Number: 152871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2015
• 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: Male