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

Model Number	02.12.0003R
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 october 2020, lot 1907913: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-11-17.No anomalies found related to the problem.To date, 63 items of the same lot have been already sold without any similar reported event.Other devices involved in the event gmk-sphere 02.07.1203r tibial tray fixed cemented # 3 r lot.1907832 (k090988), batch review performed on 14 october 2020, lot 1907832: (b)(4) items manufactured and released on 8-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, 136 items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.12.0312fr insert gmk-sphere 3r 12mm lot.1906097 (k121416) batch review performed on 14 october 2020, lot 1906097: (b)(4) items manufactured and released on 30-jul-2019.Expiration date: 2024-07-13.No anomalies found related to the problem.To date, 25 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed after 5 months from the primary surgery due to suspected infection but the tests performed excluded infection.All components were revised and a spacer was inserted( for 3 weeks).Permanent implants were installed on (b)(6) 2020.The cause of this event is a feeling of general discomfort without real pain or instability.Dr (b)(6) decided to revise the implants because the patient was not completely satisfied during the first surgery.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10755373
• Report Number: 3005180920-2020-00767
• Device Sequence Number: 13737839
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 10/29/2020

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: 09/02/2024
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 1907913
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/29/2020
• 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
• Patient Age: 73 YR
• Patient Weight: 56