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

Catalog Number	02.12.0023R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2018; lot 173657: (b)(4) items manufactured and released on 06 october 2017.Expiration date: 2022-09-25; 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 #3/13 mm r reference 02.12.0311fr (k140826); lot 173803: (b)(4) items manufactured and released on 05 september 2017.Expiration date: 2022-08-17; 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.Tibial tray fixed cemented # 3 r reference 02.07.1203r (k090988); lot 174558: (b)(4) items manufactured and released on 12 october 2017 expiration date: 2022-10-03; 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.Primary extension stem ø11mm / l 30 mm reference 02.07.F11030 (k133630); lot 157706: (b)(4) items manufactured and released on 26 february 2016.Expiration date:2021-01-24; 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 2 months after the primary.The patient was (b)(6) for (b)(6).The surgeon removed all hardware and implanted a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2016 we were informed that on (b)(6) 2018 the spacer was removed and permanent implants were put in.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7425014
• Report Number: 3005180920-2018-00234
• Device Sequence Number: 1273836
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 09/25/2022
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 173657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: 64 YR