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

Catalog Number	02.12.0024R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2018; lot 171028: (b)(4) items manufactured and released on 23 may 2017.Expiration date: 2022-05-08; 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.Other devices involved: reference 02.07.1204r (k090988) tibial tray fixed cemented # 4 r; lot 170444: (b)(4) items manufactured and released on 07 june 2017.Expiration date: 2022-05-17; 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 02.12.0412fr (k121416) tibial insert fixed sphere flex #4/12 mm r; lot 172821: (b)(4) items manufactured and released on 13 july 2017.Expiration date:2022-06-23; 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.
Event or Problem Description
The patient came in due to signs of infection.[pathogen: staph.Coagulase-negative].The surgeon revised all hardware and implanted a spacer, on an unknown date.The surgeon implanted permanent hardware on (b)(6) 2018.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ 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: 7832921
• Report Number: 3005180920-2018-00645
• Device Sequence Number: 2013064
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• 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
• 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): 08/30/2018

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: 05/08/2022
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 171028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial 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