MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 3/10; TIBIAL COMPONENT FULL PE

Catalog Number	02.07.0310APPS
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 23 february 2018.Partial revision of cemented full-pe tka after 1,5 years.The information received is rather scarce, and we cannot draw any conclusion.From one of the scan sections, it appears that the cement mantle has been locally discontinued or fractured, but no cause can be ascertained.However, there is no indication of component failure, and therefore we have no indication that a defective component may be responsible for the revision.Batch review performed on 26 february 2018 lot 148558: (b)(4) items manufactured and released on 20 april 2015.Expiration date: 2020-03-31 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed due to pain about 1 year and 7 months after primary.The full-pe ps tibial component it seems was not mobilized, signs of lucency were visible on the x-rays.

• Brand Name: GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 3/10
• Common Device Name: TIBIAL COMPONENT FULL PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7309103
• Report Number: 3005180920-2018-00112
• Device Sequence Number: 16416718
• Product Code: JWH
• UDI-Device Identifier: 07630030817014
• UDI-Public: 07630030817014
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131310
• 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): 03/02/2018

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: 03/31/2020
• Device Catalogue Number: 02.07.0310APPS
• Device Lot Number: 148558
• 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: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• 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