MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; CEMENTED TIBIAL TRAY

Catalog Number	02.12.T3I4R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2019: lot 162191: 31 items manufactured and released on 31-may-2016.Expiration date: 2021-may-16.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Additonal implant involved: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.164131.Batch review performed on 18 november 2019: lot 164131: 120 items manufactured and released on 22-sep-2016.Expiration date: 2021-sep-08.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0411fr tibial insert fixed sphere flex size 4/11 mm r (k140826) lot.144644.Batch review performed on 18 november 2019: lot 144644: 25 items manufactured and released on 05-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot.162684 batch review performed on 18 november 2019: lot 162684: 60 items manufactured and released on 30-may-2016.Expiration date: 2021-05-12.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after 2 years and 11 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9382060
• Report Number: 3005180920-2019-01019
• Device Sequence Number: 13573229
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/27/2019

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: 05/16/2021
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 162191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/27/2019
• 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