MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

Catalog Number	02.07.1202R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2021: lot 154000: (b)(4) items manufactured and released on 07-oct-2015.Expiration date: 2020-09-21.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 1-1-2017.Additional items involved in the event: gmk-sphere 02.12.0002r femoral component sphere cemented size 2 r (k121416) lot.147225 batch review performed on 30 april 2021: lot 147225: (b)(4) items manufactured and released on 28-jan-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 1-1-2017.
Event or Problem Description
Revision surgery 5 years and 2 months after primary for knee instability due to femur and tibia subsidence.The surgery was completed successfully, gmk hinge implanted.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11847054
• Report Number: 3005180920-2021-00393
• Device Sequence Number: 17074731
• Product Code: JWH
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 05/19/2021

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: 09/21/2020
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 154000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• 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
• Patient Age: 89 YR