MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM LEFT

Catalog Number	02.09.0417H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the r&d project manager performed a visual inspection of the retrieved components and commented as follows: - hinge inlay secure fixation screw: the screw was found broken in 2 parts in correspondence to the cross section of the upper level of the tibia baseplate.One part was still inside the baseplate and the other part was inside the tibial insert.This last portion of the screw was found not damaged.It was most likely retained in the insert and not loosened in the joint.- tibia baseplate: some residual cement has been found of the distal surface of the two 5mm augments screwed to the baseplate.A big scretch and dent is present in the internal proximal surface of the baseplate.It has been most likely caused during the explantation of the component.It is not generated by a third body in the joint since the tibia insert doesn't present any signs of damage.Some scratches and dents can be noted in the surface of theaugments probably generated during the ablation of the component.- tibia insert: no defects relevant for the event analysis can be noted on the explanted component.- hinge post and hinge post screw: no elements relevant for the event analysis can be noted on the explanted component.Conclusion: from visual inspection it is not possible to identify any possible root cause for the event.No elements can lead suppose that the event is implant related.We can only confirm surgeon's hypotesis, reported in the event description, that patient's fall caused the breakage of the screw and could have played role in the loosening of the tibia component.On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: total knee revision surgery occurred 3 years after primary implantation of a hinged system.Radiographic image provided shows the presence of a broken insert fixation screw and radiolucent lines around the tibial component.On the basis of the information collected, it is not possible to determine which of the two events occurred first.According to the report, these events may be due to a traumatic event but the real cause cannot be determined.Ther tibial component appears to be loose from the pre-revision radiograph: this situation, in a highly costrained device, may have led to unpredictable stresses even on the insert fixation screw and result in fracture.Batch reviews performed on (b)(4) 2017.Lot 122731ar:(b)(4) items manufactured and released on 20 march 2014.Expiration date: 2017-10-31.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge fixed tibial tray size 4 right, code 02.09.4004r, lot.140417 (k130299).(b)(6) items manufactured and released on 12 may 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision due to tibial component (aseptic) loosening and breakage of the insert screw.The surgeon replaced the tibial component with inlay and stem and the 2 wedges.The surgery was completed successfully.The surgeon thinks that the screw breakage is a consequence of a patient fall.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM LEFT
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6944514
• Report Number: 3005180920-2017-00573
• Device Sequence Number: 1141727
• Product Code: KRO
• UDI-Device Identifier: 07630030825217
• UDI-Public: 07630030825217
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 02.09.0417H
• Device Lot Number: 122731AR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: 72 YR
• Patient Weight: 84