MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE SPHERE FEMUR CEMENTED RIGHT S6; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0006R
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-may-2021.Lot 1811361: (b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional devices involved batch review performed on 31-may-2021.Gmk-sphere 02.07.1205r tibial tray fixed cemented # 5 r (k090988) lot 1900540: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0511fr tibial insert fixed sphere flex #5/11 mm r (k140826) lot 186080: (b)(4) items manufactured and released on 27-nov-2018.Expiration date: 2023-11-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting mid-flexion instability 1 year and 9 months after the primary surgery.The surgeon revised all implants and converted the patient from a sphere knee to a hinge knee.The surgery was completed successfully.

• Brand Name: GMK-SPHERE SPHERE FEMUR CEMENTED RIGHT S6
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12024588
• Report Number: 3005180920-2021-00500
• Device Sequence Number: 17368159
• Product Code: JWH
• UDI-Device Identifier: 07630030825880
• UDI-Public: 07630030825880
• 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: 2019
• Device Explanted Year: 2021
• 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): 06/18/2021

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: 03/26/2024
• Device Model Number: 02.12.0006R
• Device Catalogue Number: 02.12.0006R
• Device Lot Number: 1811361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/18/2021
• 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
• Patient Age: 72 YR