MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM

Catalog Number	02.09.0514H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 june 2018: lot 143030: (b)(4) items manufactured and released on 16 july 2014.Expiration date: 30.06.2019 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.Clinical evaluation performed by medical affairs director on 12 june 2018: one (1) year and 5 months after implantation of a hinged total knee system, the insert fixation screw was found loose in the joint.Immediate removal and swap of the screw and visual inspection of the articular surfaces for possible damage are strongly recommended.Reasons for self unscrewing of the fixation screw are not known: one possibility is insufficient tightening torque but other conditions may also play a role.
Event or Problem Description
About 1 year and 5 months after primary the surgeon revised the patient for inlay screw unscrewing.The surgeon swapped successfully the inlay screw.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7605412
• Report Number: 3005180920-2018-00430
• Device Sequence Number: 1624175
• Product Code: KRO
• UDI-Device Identifier: 07630030825279
• UDI-Public: 07630030825279
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 06/30/2019
• Device Catalogue Number: 02.09.0514H
• Device Lot Number: 143030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/15/2018
• 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