MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0414PSF
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on (b)(6) 2018 by medical affairs director: 5 years after primary tka radiological analysis shows insert dissociation.The screw meant to secure the insert to the tibial tray is found broken: no means of determining whether this is an effect of insert dissociation or the fracture of the screw did not prevent the insert to dislocate.No former xrays are avalable to establish possible previous movements or malpositioning of the insert.The cause for this adverse event cannot be determined with the information at hand.Batch review performed on 12 january 2018 lot 114231: (b)(4) items manufactured and released on 24 january 2012.Expiration date: 2016-12-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection perforemd on 12 january 2018 by r&d project manager: screw breakage discovered after 5 years from primary surgery.The insert was found dislocated in the joint.The screw is found broken in 2 pieces at the height of the baseplate, in correspondence to the threated part of the screw.One part of the screw is still in the insert and the other in the baseplate.The bottom surface of the insert is completely damaged, with scratches and deep dents most likely caused by the relative movement between the insert and the tibia tray.The ps cam is found severely damaged in the lateral and the medial side.This was caused by the unpredictable and unexpected contact with the femoral component during flexion / extension movements.It is not possible to define if the insert dislocated as a consequence of the screw breakage or if the insert dislocated causing the breakage of the screw.It is not even possible to establish the root cause of this unlikely event.This could be happened as a consequence of an unpredictable traumatic event (e.G.:fall of the patient) or for a malpositioning of the implant during primary surgery.
Event or Problem Description
Revision 5 years after primary due to screw breakage and liner dislocation: the surgeon had to remove also the tibial component as part of the screw was stuck inside it.New tibial baseplate with stem and new thicker liner implanted.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7186041
• Report Number: 3005180920-2017-00840
• Device Sequence Number: 73049
• Product Code: JWH
• UDI-Device Identifier: 07630030817847
• UDI-Public: 07630030817847
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2012

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: 12/31/2016
• Device Catalogue Number: 02.07.0414PSF
• Device Lot Number: 114231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/12/2018
• 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
• Patient Age: 67 YR