MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED # 4/12MM

Model Number	02.07.0412PSF
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2020: lot 124107: (b)(4) items manufactured and released on 24-jan-2013.Expiration date: 2017-12-31.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 2016.
Event or Problem Description
The patient came in, 7 years after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon plans to perform a washout and poly-swap.During surgery it was discovered that the knee was well fixed and well balanced so there was no need to swap the liner.It turns out the patient fractured his patella so the doctor fixed that and said everything else was good.Infection was not confirmed and they did not remove any implants at all.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED # 4/12MM
• Common Device Name: TIBIAL INSERT PS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9706225
• Report Number: 3005180920-2020-00063
• Device Sequence Number: 3474938
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 12/31/2017
• Device Model Number: 02.07.0412PSF
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 124107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/13/2020
• 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