MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0023L
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018.Lot 161667: 22 items manufactured and released on 25 may 2016.Expiration date: 2021-03-23.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold without any similar reported event.Other devices involved: tibial insert fixed sphere flex size 3/10 mm l reference 02.12.0310fl; lot 154114: 60 items manufactured and released on 16 december 2015.Expiration date: 2020-11-28.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any similar reported event.Gmk-sphere patella resurfacing 2; lot 160951: 120 items manufactured and released on 26 april 2016.Expiration date: 2021-04-13.No anomalies found related to the problem.To date, 116 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 2 years after primary revision surgery for generic pain.The reason of pain is unknown.Femur and liner swap.Patella resurfacing performed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7876590
• Report Number: 3005180920-2018-00687
• Device Sequence Number: 2076406
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 03/23/2021
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 161667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• 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