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

Catalog Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 august 2019: lot 1811359: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-20.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 batch reviews performed on 8 august 2019: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988), lot 1810474: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-02-25.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 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot 187985: (b)(4) items manufactured and released on 25-jan-2019.Expiration date: 2024-01-09.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 02.07.0034rp patella resurfacing size 2 (k090988) lot 1810562: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 2024-02-26.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, 2 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon explanted the sphere femur cemented right s5, gmk tibial tray cemented right s4, gmk sphere insert flex right 10mm s4, and patella resurfacing s2.The surgeon implanted medacta full-pe components with antibiotic cement to act as a temporary spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 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: 8964872
• Report Number: 3005180920-2019-00736
• Device Sequence Number: 2459051
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 02/20/2024
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 1811359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/05/2019
• 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