MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L; CEMENTED FEMUR

Catalog Number	02.12.0024L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018; lot 175622: (b)(4) items manufactured and released on 23 november 2017.Expiration date: 2022-11-07; 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.Other device involved: tibial insert fixed sphere flex size 5/10 mm l reference 02.12.0510fl (k121416); lot 171055: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-06-01 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 tibial tray fixed cemented size 5 l reference 02.07.1205l (k090988); lot 174579: (b)(4) items manufactured and released on 10 october 2017.Expiration date:2022-09-28; 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 due to sepsis about 3 months after primary.The surgeon inserted antibiotic spacers.
Additional Manufacturer Narrative
On 08 august 2018 we were informed that the spacer is being removed in 1-week.Surgeon will be implanting a non-medacta revision knee.On 28 august 2018 we were informed that the new devices have been implanted.The revision surgery date was (b)(6) 2018.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7578035
• Report Number: 3005180920-2018-00403
• Device Sequence Number: 1813402
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• 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): 09/07/2018

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: 11/07/2022
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 175622
• 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: 05/10/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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
• Patient Age: 57 YR