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

Catalog Number	02.12.0003R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 october 2019: lot 173638: (b)(4) items manufactured and released on 4 october 2017.Expiration date: 2022-09-21.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.Clinical evaluation performed by medical affairs director two years after primary cmented tka a necrosis of the patella, to our knowledge completely unrelated to the previous intervention, led to knee instability.Revision was required to provide intrinsic stability to the joint as the patellar system could not contribute any longer.This problem is unrelated to the existing tka.Additional implant involved: gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm r (k121416) lot.171885.Batch review performed on 4 october 2019: lot 171885: (b)(4) items manufactured and released on 3 may 2017.Expiration date: 2022-05-09.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 implant involved: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.174558.Batch review performed on 4 october 2019: lot 174558: (b)(4) items manufactured and released on 12 october 2017.Expiration date: 2022-10-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
Revision surgery performed 1 year and 9 months after the primary due to knee instability caused by a patella necrosis.The reason of patella necrosis is unknown (no infection present).The surgeon revised the insert and femoral and tibial components.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9238376
• Report Number: 3005180920-2019-00898
• Device Sequence Number: 150743
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2022
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 173638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/25/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 80