MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED # 4 L; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018; lot 166900: (b)(4) items manufactured and released on 07 february 2017.Expiration date: 2022-01-23, 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: gmk-sphere tibial tray fixed cemented # t3-i4 l reference 02.12.T3i4l (k121416); lot 166009: (b)(4) items manufactured and released on.09 december 2016 expiration date: 2021-11-29; 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 size 4/11 mm l reference 02.12.0411fl (k140826); lot 165719: (b)(4) items manufactured and released on 21 november 2016.Expiration date: 2021-10-27; 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.Gmk-sphere patella resurfacing size 3 l reference 02.07.0035rp (k090988); lot 166404: items manufactured and released on 09 january 2017.Expiration date: 2021-02-08; 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 after primary the surgeon removed all the patient devices and implanted a spacer for a hip infection.Patient positive to staphylococcus epidermidis.The surgery was completed successfully.
Additional Manufacturer Narrative
On 31 july 2018 we were informed that the patient had the abx spacer removed.Permanent implants were put in.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED # 4 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: 7582494
• Report Number: 3005180920-2018-00405
• Device Sequence Number: 2515239
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 01/23/2022
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 166900
• 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: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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