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

Catalog Number	02.12.0023R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17january 2018 lot 165065: (b)(4) items manufactured and released on 05 oct 2016.Expiration date: 2021-09-22 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 fixed sphere flex size3/10 mm r reference 02.12.0310fr (k121416): lot 165076: (b)(4) items manufactured and released on 12 october 2016.Expiration date:2021-09-07 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 tray fixed cemented size 3 r reference 02.07.1203r (k090988): lot 164893: (b)(4) items manufactured and released on 29 sept 2016.Expiration date: 2021-09-19 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 # 2 reference 02.07.0034rp (k090988): lot 163383: (b)(4) items manufactured and released on 29 sept 2016.Expiration date: 2021-09-19 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
Revision surgery 1 year after primary was necessary due to infection.The pathogen result is not available.The surgeon revised all components and implanted a spacer.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7199218
• Report Number: 3005180920-2017-00843
• Device Sequence Number: 1043259
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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: 09/22/2021
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 165065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/17/2018
• 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