MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/14MM

Catalog Number	02.09.0114H
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 july 2024.Lot 2200965: (b)(6) items manufactured and released on 07-jun-2022.Expiration date: 2027-may-22.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department revision surgery was performed approximately one year after the implantation of a constrained hinge prosthesis.The primary reason for the revision was identified as the breakage of the inlay screw.However, the available x-rays not only show the broken screw but also the disassembling of the system, with the post having come out of its seat.The causes of the screw breakage remain unknown.The fixation of the insert was significantly compromised due to the absence of the screw.This insert was not fixed in place but was held only against rotation by the shallow perimetral wall of the tray, with no mechanism to prevent it from lifting up in case of joint distraction.This situation, combined with some degree of joint laxity, may have led to the disassembly of the prosthesis.According to the report, only the insert was replaced, which made the revision surgery not excessively traumatic for the patient and required no further bone disruption.Additional items involved in the event, batch review performed on 31 july 2024.Gmk-hinge 02.09.2601r femoral component size1 r (k130299) lot.2115094 lot 2115094: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-feb-22.No anomalies found related to the problem.To date, only this item of this lot has been sold.Gmk-hinge 02.09.4001r fixed tibial tray size1 r (k130299) lot.2116294 lot 2115094: (b)(4) items manufactured and released on 13-apr-2022.Expiration date: 2027-mar-30.No anomalies found related to the problem.To date, only this item of this lot has been sold.
Event or Problem Description
The patient came in for a post-op appointment and a post-op x-ray showed a broken poly screw and the cause is unknown.Also, the femur was found dissociated from the baseplate (post was out of its seat).About 1 year and 2 months after the primary surgery, the surgeon decided to revise the patient and revised the insert (same ref, different lot).The surgery was completed successfully.
Additional Manufacturer Narrative
E1.Initial reporter: the city address reported in the initial report (villaneuve la garenne) was incorrect, it was deleted.
Event or Problem Description
The patient came in for a post-op appointment and a post-op x-ray showed a broken poly screw and the cause is unknown.The femur was found dissociated from the baseplate (post was out of its seat) and the liner was also dissociated from the baseplate.About 1 year and 2 months after the primary surgery, the surgeon decided to revise the patient and revised the insert (same ref, different lot; the rest of the broken screw was removed with a sharp 1/4 inch osteotome).The surgery was completed successfully.The surgeon believes that the root cause of the implant failure is directly associated with the patella tendon issues that created the instability.We trialed a thicker poly but, it was not possible to go larger.After replacing the broken screw/poly, there was an extensive patella tendon repair done.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department: revision surgery was performed approximately one year after the implantation of a constrained hinge prosthesis.The primary reason for the revision was identified as the breakage of the inlay screw.However, the available x-rays not only show the broken screw but also the disassembling of the system, with the post having come out of its seat.The causes of the screw breakage remain unknown.The fixation of the insert was significantly compromised due to the absence of the screw.This insert was not fixed in place but was held only against rotation by the shallow perimetral wall of the tray, with no mechanism to prevent it from lifting up in case of joint distraction.This situation, combined with some degree of joint laxity, may have led to the disassembly of the prosthesis.
Additional Manufacturer Narrative
On 09 oct 2024, follow up 3 was sent to correct the batch of the tibial tray.Batch review performed on 31 jul 2024.Gmk-hinge 02.09.4001r fixed tibial tray size 1 r (k130299) lot 2116294: (b)(4) items manufactured and released on 13-apr-2022.Expiration date: 2027-mar-30.No anomalies found related to the problem.To date, (b)(4) items of this lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
In the initial report, it was reported that the device was available.However, the device has not yet been received therefore we consider it unavailable.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 1/14MM
• Common Device Name: FIXED 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: 20083675
• Report Number: 3005180920-2024-00653
• Device Sequence Number: 20795391
• Product Code: KRO
• UDI-Device Identifier: 07630030824999
• UDI-Public: 07630030824999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/05/2024

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 Catalogue Number: 02.09.0114H
• Device Lot Number: 2200965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/25/2024; 10/09/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2022
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 165 KG
• Patient Race: White