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

Model Number	02.12.0005L
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-apr-2021: lot 165041: (b)(4) items manufactured and released on 27-oct-2016.Expiration date: 2021-10-16.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2017.Another device involved: batch review performed on 15-apr-2021: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.166052: (b)(4) items manufactured and released on 11-jan-2017.Expiration date: 2021-10-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.
Event or Problem Description
Revision surgery performed due to femur and tibial tray loosening 3 years and 10 months after the primary surgery.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11670242
• Report Number: 3005180920-2021-00301
• Device Sequence Number: 3160706
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 04/15/2021

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: 10/16/2021
• Device Model Number: 02.12.0005L
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 165041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• 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