MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L; FEMUR CEMENTED

Catalog Number	02.07.2005L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2018: lot 135484: (b)(4) items manufactured and released on 19 december 2013.Expiration date: 2018-11-30.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.Gmk-primary tibial tray fixed cemented size 5 l reference 02.07.1205l (k090988).Lot 153511: (b)(4) items manufactured and released on 06 october 2015.Expiration date: 2020-08-31.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.Gmk-primary tibial insert uc fixed size 5 / 10 mm reference 02.07.0510fuc (k090988).Lot 147976: (b)(4) items manufactured and released on 27 april 2015.Expiration date: 2020-03-31.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.Gmk-primary patella resurfacing size 3 reference 02.07.0035rp (k090988).Lot 154112: (b)(4) items manufactured and released on 29 october 2015.Expiration date: 2020-10-06.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.
Event or Problem Description
The patient called fda to report that since he has been implanted with a total knee implant, he has had pain, discomfort and loss of range of motion; the implant is at ten percent deflexion.The reporter has been told by three healthcare "professional" that his knee implant is unstable and exploratory surgery is needed."there are no record" of the revision surgery being performed.
Additional Manufacturer Narrative
On march 13, 2019 we received the notification of a new complaint (b)(4), originally registered due to mistake, as it was not detected as a duplicate of the current case.The new information received are consequently added to this mdr: "the patient came in complaining of mid-flexion instability.The surgeon removed all medacta implants on (b)(6) 2019 and revised the knee with another company's product.The surgery was completed successfully".

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8105811
• Report Number: 3005180920-2018-00947
• Device Sequence Number: 11261879
• Product Code: JWH
• UDI-Device Identifier: 07630030820236
• UDI-Public: 07630030820236
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 11/30/2018
• Device Catalogue Number: 02.07.2005L
• Device Lot Number: 135484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 04/10/2019
• 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