MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2018: lot 171823: (b)(4) items manufactured and released on 28-aug-2017.Expiration date: 2022-08-15.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.Additional implants revised: gmk-sphere 02.12.0510fr tibial insert fixed sphere flex #5/10 mm r, lot 172824: (b)(4) items manufactured and released on 25-jul-2017.Expiration date: 2022-07-03.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 gmk-sphere 02.07.1205r tibial tray fixed cemented # 5 r, lot.171962: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 2022-09-05.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 02.07.0034rp patella resurfacing # 2, lot.174636: (b)(4) items manufactured and released on 11-oct-2017.Expiration date: 2022-09-21.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 11 months after the primary surgery.The surgeon performed a washout and revised all hardware.The pathogen is unknown.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164771
• Report Number: 3005180920-2018-01000
• Device Sequence Number: 2027557
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 08/15/2022
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 171823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/14/2018
• 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