MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R; KNEE FEMUR IMPLANT

Model Number	02.07.2206R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 march 2020: lot 110639: (b)(4) items manufactured and released on 28-mar-2011.Expiration date: 2016-02-29.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.Additional device involved: batch review performed on 11 march 2020: gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r ((b)(4)) lot 112938: (b)(4) items manufactured and released on 29-nov-2011.Expiration date: 2016-10-31.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.Preliminary investigation performed by medacta knee r&d manager.Revision surgery after 8 years from primary for suspected loosening of the femoral and the tibial component.Looking at the picture of the explanted components, no residual cement can be seen on the distal surface of the tibia tray and the internal surface of the femoral component.This is common findings on explanted components even if the cause for revision is not loosening.So, absence of cement on explanted components is not an evidence of a faulty device.Many other factors (such as bone quality reduction, osteolysis, traumatic event), could had played a role during time in reducing performances of interdigitation between implant and cement on both tibial and femoral side.No other aspects relevant for the event can be noted on explanted components.
Event or Problem Description
The patient came in, 8 years after primary surgery, for a post-op appointment, and the surgeon determined that the patient's bone scan showed loose implants.During the revision surgery, the surgeon observed that the cement did not bond to any of the implants.The surgeon revised all implants and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R
• Common Device Name: KNEE FEMUR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9846881
• Report Number: 3005180920-2020-00159
• Device Sequence Number: 16329402
• Product Code: JWH
• UDI-Device Identifier: 07630030820892
• UDI-Public: 07630030820892
• 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: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 02/29/2016
• Device Model Number: 02.07.2206R
• Device Catalogue Number: 02.07.2206R
• Device Lot Number: 110639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/18/2020
• 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