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

Model Number	02.12.0004L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31.Mar.2021: lot 147682: 57 items manufactured and released on 21.01.2015.Expiration date: 2019-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with 1 similar reported event since 2017.Additional implant involved: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.155178.Batch review performed on 31.Mar.2021: lot 155178: 71 items manufactured and released on 15.12.2015.Expiration date: 2020-11-28.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Additional implant involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.165489.Batch review performed on 31.Mar.2021: lot 165489: 46 items manufactured and released on 21.11.2016.Expiration date: 2021-11-08.No anomalies found related to the problem.To date, 42 items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director.Tibial failure in both knees 5 years after bilateral primary cemented tka.The migration of the two tibial baseplates is macroscopic.We only got pre-revision radiographs, so we cannot evaluate if the migration took place immediately after the operation, progressively over the years, or suddenly before revision.For the same reasons, no conclusions can be drawn with the information at hand.There is no clue leading towards a defect in the implanted devices.
Event or Problem Description
Revision surgery performed 4 years and 10 months after the primary surgery due to due to left site tibial tray subsidence and mobilization of the femoral component (the patient is bilateral).The right side tibial component is mobilized and will be revised later (right knee primary surgery was performed on (b)(6) 2017).
Additional Manufacturer Narrative
On 28-apr-2021 we received the planning review relative to right knee primary surgery.Patient match planning review performed by my solution department the analysis regards the right site.The left side implants were installed without patient match.We analyzed each step of the myknee process; no errors have been found.Our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11715542
• Report Number: 3005180920-2021-00317
• Device Sequence Number: 3764966
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• 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,Followup
• Report Date (Section B): 05/27/2021

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: 11/30/2019
• Device Model Number: 02.12.0004L
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 147682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: 71 YR
• Patient Weight: 90