MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0021R
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2020: lot 173655: (b)(4) items manufactured and released on 10-nov-2017.Expiration date: 2022-10-18.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 02.12.0110crr tibial insert fixed sphere cr #1/10 mm r lot.185604 (k181635) batch review performed on 03 september 2020: lot 185604: (b)(4) items manufactured and released on 20-sept-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 02.07.1201r tibial tray fixed cemented # 1 r lot.177227 (k090988) batch review performed on 03 september 2020: lot 177227: (b)(4) items manufactured and released on 05-feb-2018.Expiration date: 2023-01-23.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 reporting instability due to developing a medial collateral ligament rupture.The cause of the rupture is unknown.11 months after primary the surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10567153
• Report Number: 3005180920-2020-00632
• Device Sequence Number: 2704626
• Product Code: JWH
• UDI-Device Identifier: 07630030862458
• UDI-Public: 07630030862458
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 10/18/2022
• Device Model Number: 02.12.0021R
• Device Catalogue Number: 02.12.0021R
• Device Lot Number: 173655
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/22/2020
• 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