MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L; KNEE TIBIAL BASEPLATE CEMENTED

Model Number	02.07.1203L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 december 2021: lot 122122: (b)(4) items manufactured and released on 09-aug-2012.Expiration date: 2017-jun-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-1-2017.Additional component involved: gmk-primary 02.07.2204l femur ps cemented size 4 l (k090988) lot.112990.Lot 112990: (b)(4) items manufactured and released on 06-oct-2011.Expiration date: 2016-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-1-2017.
Event or Problem Description
Revision surgery at 9 years and 1 month after primary due to femur and tibial implant mobilization.All implants revised successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director at 9 years after primary tka both components mobilize quite significantly, while the patella remains well fixed.No traumatic event is reported, and no infection.The reasons for such a sudden and macroscopic loosening are not known and cannot be determined with the information at hand.Idiopathic aseptic loosening is a possible adverse event following tka, reported in literature.There is no reason to suspect faulty devices, with the information at hand.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: KNEE TIBIAL BASEPLATE CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13060403
• Report Number: 3005180920-2021-01002
• Device Sequence Number: 1609105
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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,Followup
• Report Date (Section B): 01/21/2022

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: 06/30/2017
• Device Model Number: 02.07.1203L
• Device Catalogue Number: 02.07.1203L
• Device Lot Number: 122122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White