MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

Catalog Number	02.12.0005L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2019: lot 179611: (b)(4) items manufactured and released on 11-apr-2018.Expiration date: 2023-07-27.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 02.07.1205l tibial tray fixed cemented size 5 l lot.180256 (k090988) batch review performed on 16 december 2019: lot 180256: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-may-08.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 02.07.0036rp patella resurfacing size 4 lot.155779 (k113571) batch review performed on 16 december 2019: lot 155779: (b)(4) items manufactured and released on 28-jan-2016.Expiration date: 2021-01-11.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
About 1 year and 2 months after primary the patient came in complaining of instability.The surgeon observed that all the components were loose and that the cement did not hold during the primary surgery.The surgeon revised the femoral component, tibial tray, poly, and patella.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9523296
• Report Number: 3005180920-2019-01097
• Device Sequence Number: 19508999
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• 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: 2018
• 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): 12/27/2019

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: 07/27/2023
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 179611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/27/2019
• 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