MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / LEFT; CEMENTED FEMUR

Catalog Number	02.07.2214L
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2018.Lot 151533: (b)(4) items manufactured and released on 11 june 2015.Expiration date: 2021-03-15.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.Other devices involved: tibial tray fixed cemented size 3 l reference 02.07.1203l (k090988).Lot 156116: (b)(4) items manufactured and released on 20 january 2016.Expiration date: 2021-01-10.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.Tibial insert ps fixed size 3/10mm reference 02.07.0310psf (k090988).Lot 143610: (b)(4) items manufactured and released on 02 october 2014.Expiration date: 2019-08-31.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.Patella resurfacing size 2 reference 02.07.0034rp (k090988).Lot 160181: (b)(4) items manufactured and released on.Expiration date: 2021-04-03.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 medacta us complaining of pain.The patient will likely undergo additional surgery.The date of the revision is unknown.The revising surgeon is unknown.No additional information will be provided by the patient.
Additional Manufacturer Narrative
In the initial report due to typo it was not reported the manufacturing date of the lot: 160181.Lot: 160181: (b)(4) items manufactured and released on 20 april 2016.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / LEFT
• Common Device Name: CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7718471
• Report Number: 3005180920-2018-00537
• Device Sequence Number: 1120933
• Product Code: JWH
• UDI-Device Identifier: 07630030820984
• UDI-Public: 07630030820984
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 03/15/2021
• Device Catalogue Number: 02.07.2214L
• Device Lot Number: 151533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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