MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0024L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Total knee revision surgery occurred 4 years after cemented total knee arthroplasty in a (b)(6) patient due to tibial and femoral parts loosening.From the picture of the explants, we observe that no cement adhered to the metal components and this might be a sign of a problem occurred during the cementation procedure.Several variables can influence the cementation process such as temperature (of the implant and of the room), time of insertion, presence of liquids, possible accidents during cement transportation or storage (e.G.Temporary temperature increase), and other possibilities not related to the implant.Also, a peculiar situation is observed in the lateral projection behind the trochlear surface whose clinical relevance cannot be determined with the information at hand.The reason of this event cannot be determined.Batch review performed on 01 march 2022: lot 174835: 70 items manufactured and released on 10-oct-2017.Expiration date: 2022-09-25.No anomalies found related to the problem.To date, 69 items of the same lot have been sold without any similar reported event since 1-1-2018.Additional device involved: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.174579: 153 items manufactured and released on 10-oct-2017.Expiration date: 2022-09-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-1-2018.
Event or Problem Description
At 4 years and 1 month after primary, revision surgery for tibia and femur implants loosening.Femur, tibial tray and liner revised successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: KNEE FEMORAL COMPONENT 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: 13770426
• Report Number: 3005180920-2022-00185
• Device Sequence Number: 19859711
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 03/15/2022

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: 09/25/2022
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 174835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2017
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White