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

Model Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2020: lot 1905069: (b)(4) items manufactured and released on 04-oct-2019.Expiration date: 2024-09-23.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 implant involved: gmk-sphere 02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot.1906101.Batch review performed on 06 august 2020: lot 1906101: (b)(4) items manufactured and released on 20-jul-2019.Expiration date: 2024-07-16.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 implant involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.1905256.Batch review performed on 04 august 2020: lot 1905256: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-06.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
Patient complaints of knee pain.The knee is infected.He attended steroid injection.The patient has been revised due to infection 6 months after primary.
Additional Manufacturer Narrative
On the 15 september 2020 medacta usa reported that the devices involved in the complaint are not available.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10464400
• Report Number: 3005180920-2020-00550
• Device Sequence Number: 2925375
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 09/23/2024
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 1905069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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: 60 YR
• Patient Weight: 90