MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0314H FIXED TIBIAL INSERT SIZE 3/14MM; KNEE FIXED TIBIAL INSERT

Model Number 02.09.0314H

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Luxation of the hinge inlay, when the patient stood up from a chair.During the revision, the screw of the inlay was broken.The screw of the hinge mechanism was correctly fixated.Revision surgery performed 3 months after the primary surgery; only insert revised with a higher one (from 14 mm to 20 mm).A big laxity was observed during revision.

Manufacturer Narrative

Batch review performed on 11 july 2022 lot 2108837: (b)(4).Expiration date: 2026-sep-06.No anomalies found related to the problem.(b)(4).Clinical evaluation performed by medical affairs director: few weeks after implantation of a hinged tka, the system disassembles in absence of a significant trauma.The insert fixation screw is visibly broken, but this may not be the most relevant circumstance.It is very likely that the screw broke during index surgery.However, the post got out of its seat, and this may only be due to a severe laxity that probably has intervened after surgery.It is conceivable that the concomitance of the two factors, laxity and broken screw, has made disassembly a little easier, assuming that the insert has been sucked out of its seat by the femoral component.In our opinion, the root cause is severe laxity.According to report, only the insert has been replaced, which made the revision surgery not excessively traumatic for the patient and required no further bone disruption.Preliminary investigation performed by r&d manager: revision surgery of a gmk hinge implant after 3 months from primary implantation due to luxation of the tibial insert while the patient was standing up from a chair.The tibial insert looks damaged and deformed on the final portion of the central cone.The tibial insert secure screw is broken.Severe laxity was discovered and reported during the revision surgery.This laxity, progressively occurred in the patient after the primary surgery, could be the cause of this unlikely event of luxation.Laxity could also have lead to unexpected loading conditions that could have played a role also in the breakage of the insert secure screw.From preliminary investigation, there is no evidence that the event is related to a faulty device, but more likely related to a progressive patient disease.Other devices involved: batch review performed on 12 july 2022.Gmk-hinge 02.09.4003l fixed tibial tray size 3 l (k130299) lot 2009809: (b)(4).Expiration date: 2025-nov-08.(b)(4).Gmk-hinge 02.09.2604l femoral component size 4 l (k130299) lot 2003428: (b)(4).Expiration date: 2025-may-25.No anomalies found related to the problem.(b)(4).

Manufacturer Narrative

On 05th august 2022 we have received the pieces back.Visual inspection performed by r&d project manager.From visual inspection, we can confirm that the tibial insert looks damaged and deformed on the final portion of the central cone.The tibial insert secure screw is broken also.Severe laxity was discovered and reported during the revision surgery.The 14mm thick insert implanted in the primary surgery has been replaced by a 20mm.This laxity, progressively occurring in the patient after the primary surgery, could be the cause of this unlikely event of luxation.Laxity could also have led to unexpected loading conditions that could have also played a role in the breakage of the insert screw.From visual inspection, there is no evidence that the event is related to a faulty device, rather it is more likely related to a rapid progress of the patient's disease.

• Brand Name: GMK-HINGE 02.09.0314H FIXED TIBIAL INSERT SIZE 3/14MM
• Type of Device: KNEE 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15147140
• MDR Text Key: 297068208
• Report Number: 3005180920-2022-00577
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825132
• UDI-Public: 07630030825132
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.0314H
• Device Catalogue Number: 02.09.0314H
• Device Lot Number: 2108837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White