MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

Catalog Number	02.12.0026R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2019: lot 171838: 26 items manufactured and released on 28 august 2017.Expiration date: 2022-06-29.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold with one similar reported event.Other implants involved in the event, batch review performed on 13 december 2019.Gmk-sphere 02.07.0035rp patella resurfacing # 3 (k090988) lot.173745.Lot 173745: 120 items manufactured and released on 19 september 2017.Expiration date: 2022-08-30.No anomalies found related to the problem.To date, 119 items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.1205r tibial tray fixed cemented # 5 r (k090988) lot.171961.Lot 171961: 109 items manufactured and released on 7 september 2017.Expiration date: 2022-08-28.No anomalies found related to the problem.To date, 109 items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.12.0514fr tibial insert fixed sphere flex # 5/14 mm r (k121416) lot.134449 lot 134449: 25 items manufactured and released on 13 november 2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.173740 lot 173740: 100 items manufactured and released on 4 october 2017.Expiration date: 2022-09-21.No anomalies found related to the problem.To date, 90 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 an infection and the pathogen was unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9502122
• Report Number: 3005180920-2019-01095
• Device Sequence Number: 1215594
• Product Code: JWH
• UDI-Device Identifier: 07630030862441
• UDI-Public: 07630030862441
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 06/29/2022
• Device Catalogue Number: 02.12.0026R
• Device Lot Number: 171838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/20/2019
• 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