MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/17MM

Model Number	02.09.0117H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2020: lot 124929ar: (b)(4) items manufactured and released on 11-mar-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 since 1-1-2016.Clinical evaluation performed by medical affairs director: 3.5 years after knee revision, the patient feels instability and it is found that the knee has acquired laxity and the insert locking screw is broken.Surgery is therefore undertaken to replace the insert with a thicker one (from 17 to 23 mm) and the locking screw is also replaced.The metal components were found to be very solid and therefore left in place.We don't know if the root cause for revision was the finding of a broken screw or the need for additional stability, to be sought with a thicker insert.It is unclear if the broken screw remained in situ or not; we couldn't locate it on the xray.According to report, there was no damage to the main components.Preliminary investigation performed by r&d project manager.Preliminary investigation based on the pictures in our hand.3.5 years after knee revision surgery, the patient complaints instability and it is found that the knee has acquired laxity and the insert locking screw is broken.The inlay screw broke in its threaded shaft, at the level of the cantilevered portion of the screw when fixed in the baseplate.Cause for screw breakage remains unknown, we can only suppose that progressive instability could have led unpredictable loads acticting on the joint and early failure of the device.The revision surgery is therefore undertaken to replace the insert with a thicker one (from 17 to 23 mm) and the locking screw is also replaced.At the time of the surgery, both tibial tray and femoral component were found to be solid and therefore left in place.We don't know if the root cause for revision was the finding of a broken screw or the need for additional stability, to be replaced with a thicker insert.According to report, there were no damage to the main components.
Event or Problem Description
The patient complained knee instability.3 years and 4 moths after primary surgery the surgeon revised the patient knee finding the inlay screw broken (liner fixation screw).Only the liner was swapped during the surgery.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 1/17MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10161717
• Report Number: 3005180920-2020-00337
• Device Sequence Number: 16807694
• Product Code: KRO
• UDI-Device Identifier: 07630030825002
• UDI-Public: 07630030825002
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 10/31/2017
• Device Model Number: 02.09.0117H
• Device Catalogue Number: 02.09.0117H
• Device Lot Number: 124929AR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/17/2020
• 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