MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS #5NARROW / LEFT; KNEE FEMUR CEMENTED

Catalog Number	02.07.2215L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2019.Lot 154097: 10 items manufactured and released on 28-sep-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by r&d knee manager: from preliminary investigation based on the picture of the explanted components, no residual cement can be seen on the distal surface of the tibia tray.Some residual cement is present on the distal internal surface of the femoral component.This is common finding on explanted components even if the cause for revision is not loosening; absence of cement on explanted components is not an evidence of a faulty device.Many other factors (like temperature, time) during cementation process could had played a role 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.Other implant involved in the event, batch review performed on 14 november 2019.Gmk-primary 02.07.1203l tibial tray fixed cemented # 3 l (k090988) lot.155748 lot 155748: 66 items manufactured and released on 29-dec-2015.Expiration date: 2020-12-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of stiffness in the knee.The surgeon observed that the patient's tibia and femur were not well-fixed.The femur and tibia were easily removed from the patient without any cement on the implants.The surgeon revised the femur, insert, and tibial tray 1 year and 5 months after primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS #5NARROW / LEFT
• Common Device Name: KNEE FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9443371
• Report Number: 3005180920-2019-01032
• Device Sequence Number: 2972624
• Product Code: JWH
• UDI-Device Identifier: 07630030821004
• UDI-Public: 07630030821004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 08/31/2020
• Device Catalogue Number: 02.07.2215L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/10/2019
• 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