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	Unspecified Infection (1930)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 september 2018.Lot 165045: (b)(4) items manufactured and released on 26 september 2016.Expiration date: 2021-09-13.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.Reference 02.12.0310fl, (k121416), tibial insert fixed sphere flex size 3/10 mm l.Lot 166017: (b)(4) items manufactured and released on 21 november 2016.Expiration date: 2021-11-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-sphere reference 02.07.1203l, (k090988), tibial tray fixed cemented size 3 l.Lot 166046: (b)(4) items manufactured and released on 21 december 2016.Expiration date: 2021-12-11.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
About 1 year and 3 months after primary the patient called the agent complaining about a revision she had to undergo.The patient explained that she was revised due to potential infection.The patient was revised by a non medacta surgeon.

• 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: 7868586
• Report Number: 3005180920-2018-00671
• Device Sequence Number: 13972041
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 09/13/2021
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 165045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/12/2018
• 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