MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0004R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03.Sep.2019: lot 151997: 41 items manufactured and released on 11-jun-2015.Expiration date: 30/04/2020.No anomalies found related to the problem.To date, all 41 items of the same lot have been already sold without any other similar reported event.Additional devices involved.Batch reviews performed on 03.Sep.2019: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot 153119: 49 items manufactured and released on 11-jun-2015.Expiration date: 30/04/2020.No anomalies found related to the problem.To date, all the 49 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm (k121416) lot 148390: 50 items manufactured and released on 20 august 2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, all the 50 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of limited range of motion after about 4 years.The surgeon revised the femoral component, tibial tray and poly and the surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9097723
• Report Number: 3005180920-2019-00786
• Device Sequence Number: 3587219
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• 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: 2015
• 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): 09/20/2019

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: 04/30/2020
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 151997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• 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