MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0022R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 june 2019: lot 183454: (b)(4) items manufactured and released on 18jul-2018.Expiration date: 2023-07-04.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 implants involved in the event, batch review performed on 13 june 2019: gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416): lot 176166: (b)(4) items manufactured and released on 20-feb-2018.Expiration date: 2023-02-05.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 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.177229: (b)(4) items manufactured and released on 22-feb-2018.Expiration date: 2023-02-12.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 5 months and a half after primary the surgeon revised the patient knee for a infection.The patient had a septic arthritis.Femur, tibia and insert revised successfully.The pathogen is unknown.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8762570
• Report Number: 3005180920-2019-00535
• Device Sequence Number: 13963012
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• 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): 07/04/2019

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: 07/04/2023
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 183454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/04/2019
• 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: 71 YR
• Patient Weight: 68