MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0022R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 jun 2019: lot 181857: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-05-31.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.Additional items involved in the event, batch review performed on 14 jun 2019: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988), lot.187294.Lot 187294: (b)(4) items manufactured and released on 13-sep-2018.Expiration date: 2023-09-05.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 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416), lot.181893.Lot 181893: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-10.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
7 months after the primary the patient had knee pain and stiffness.Revision surgery was planned on (b)(6) 2019, we did not receive any additional information about.
Event or Problem Description
Revision surgery performed successfully 7 months after primary.The surgeon revised the femoral component, tibial tray, and poly.
Additional Manufacturer Narrative
On (b)(6) 2019 we became aware that the revision surgery was performed successfully.Surgeon removed the femur, tibia and insert.Cause of pain was stiffness and insufficient range of motion.
Additional Manufacturer Narrative
On (b)(6) 2019 we received the confirmation of the revision surgery date and outcome.
Event or Problem Description
Revision surgery scheduled for (b)(6) 2019, 7 months after the primary due to pain and stiffness and insufficient range of the motion.The surgeon revised the femoral component, tibial tray, and poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8762568
• Report Number: 3005180920-2019-00531
• Device Sequence Number: 2039656
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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: 05/31/2023
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 181857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 06/04/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 08/02/2019; 09/18/2019
• 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