MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0310FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain.The surgeon observed that the patients mcl (medial collateral ligament) was not functioning properly and was unstable and the cause is unknown.At about 3 weeks post primary the surgeon revised the tibia, femur, and insert with hinge components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14 february 2023: lot 2215751: (b)(4) manufactured and released on 28-sep-2022.Expiration date: 2027-09-04.No anomalies found related to the problem.To date, 20 items of the same lot have been sold without any similar reported event in the period of review.Additional components involved: gmk-sphere 02.12.0003l femoral component sphere cemented size 3 l (k121416) lot.2208585: 39 items manufactured and released on 30-june-2022.Expiration date: 2027-06-19.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.2212086: (b)(4) manufactured and released on 28-set-2022.Expiration date: 2027-09-12.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
On 13 september 2023, we have received the item involved in the event.Visual inspection performed by r&d project manager: looking at the stem it is clearly visible that the stem taper is connected with an high offset sleeve of a competitor (merete bioball) that is not approved by medacta and is connected with a ceramic head 36mm diameter.We have measured the resulting offset (from resection line to the top of the femoral head) finding that it is approximately 73mm, 6mm larger than the maximum offset expected with the use of medacta heads 36 xxl connected with minimax size 4 (67mm).This situation is critical in terms of fatigue mechanical resistance of the neck because the level arm is increased, introducing a new worst-case in respect to what was tested and validated by medacta.Additionally, in the ifu of merete bioball the following statement is reported: "no biomechanical testing information is available on the usage of bioball adapters with hip stems from other manufacturers.Consequently, only manufacturer-approved extensions may be used", confirming the improper usage with medacta stems.Morever, looking at the neck surfaces some signs and scratches are present.It is not possible to understand if the signs were caused during the last revision surgery or if they were present before the neck breakage.We have analyzed the fracture section on the neck with a microscope and we found also a slight burn mark in the inner surface.It seems that the surgon hit the neck surface with an electrocautering device during revision surgery.Additionally, the breakage pattern suggests that the crack started from the lateral side and then moved medially until the breakage occurs.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16495667
• Report Number: 3005180920-2023-00052
• Device Sequence Number: 12336487
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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 Model Number: 02.12.0310FL
• Device Catalogue Number: 02.12.0310FL
• Device Lot Number: 2215751
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2023
• Supplement Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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 Sex: Female