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

Model Number	02.12.0003R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 184850: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-03.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 item involved in the event, batch review performed by medacta regulatory affairs department on 10.09.2020: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.182902 lot 182902: (b)(4) items manufactured and released on (b)(6) 2018.Expiration date: 2023-09-02.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 pain due to an aseptic loosening of the femoral and tibial components 1 year and 7 months after the primary surgery.The surgeon removed all implants and revised them with competitor products.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10604907
• Report Number: 3005180920-2020-00652
• Device Sequence Number: 16464128
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 09/03/2023
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 184850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/30/2020
• 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