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

Catalog Number	02.09.0117H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the torque-limiting driver was used in the primary surgery.Batch review performed on 23 april 2019: lot 181164: (b)(4) items manufactured and released on 05-apr-2018.Expiration date: 2023-03-19.No anomalies found related to the problem.To date, no other items of this lot have been already sold.Clinical evaluation performed by medical manager: disassembly of a constrained tka less than two months after surgery.The connecting screw came loose and the device disassembled.One possible cause for spontaneous disassembly is insufficient tightening torque: this mechanism has been reproduced in laboratory experiments.Other unknown situations may also play a role.The time to failure is remarkably low and leads to think that the initial torque may have been inadequate.However, no final conclusion can be drawn with the available information.
Event or Problem Description
Revision surgery performed 2 months form the primary due to instability caused by the setscrew and yolk becoming disassociated with the axel pin of the hinge insert.The surgeon revised the 17mm insert with a 23mm insert.The surgeon was able to seat the morse taper on the axle pin and the setscrew was repositioned and torqued using the torque-limiting driver.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 1/17MM
• Common Device Name: POLYETHYLENE KNEE INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8555113
• Report Number: 3005180920-2019-00310
• Device Sequence Number: 16721482
• Product Code: KRO
• UDI-Device Identifier: 07630030825002
• UDI-Public: 07630030825002
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 03/19/2023
• Device Catalogue Number: 02.09.0117H
• Device Lot Number: 181164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/26/2019
• 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