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

Model Number	02.12.0024L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 january 2020: lot 179598: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3-i4 l lot.186163 (k121416).Batch review performed on 8 january 2020: lot 186163: (b)(4) items manufactured and released on 7-nov-2018.Expiration date: 2023-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.Fsc11065 extension stem cemented ø 11 l 65 lot.188134 (k120790).Batch review performed on 8 january 2020: lot 188134: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0412fl tibial insert fixed sphere flex size 4/12 mm l lot.171051 (k121416) batch review performed on 8 january 2020: lot 171051: (b)(4) items manufactured and released on 12-jun-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 other similar reported event.Gmk-sphere 02.07.0034rp patella resurfacing size 2 lot.188119 (k090988).Batch review performed on 8 january 2020: lot 188119: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed 10 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware, performed a washout and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9610264
• Report Number: 3005180920-2020-00004
• Device Sequence Number: 523726
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 03/13/2023
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 179598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/21/2020
• 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