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

Catalog Number	02.12.0023R
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2018.Lot 160142: (b)(4) items manufactured and released on 22 march 2016.Expiration date: 2021-03-06 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.Other device involved: tibial insert fixed sphere flex #2/14 mm r reference 02.12.0214fr (k121416) lot 154770: (b)(4) items manufactured and released on 20 january 2016.Expiration date: 2021-01-05 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.Patient match investigation done on 22 august 2018.Our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
The patient came in complaining of pain 1 year and 9 months after primary: the mcl had ruptured.Post mcl repair the surgeon noticed that the patient presented with a valgus alignment: he recut the femur to fit a size 3 gmk revision ps femur and revised also insert.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7812472
• Report Number: 3005180920-2018-00630
• Device Sequence Number: 16408483
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• 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): 08/24/2018

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: 03/06/2021
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 160142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/24/2018
• 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