MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0002L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2018: lot: 171791: (b)(4) items manufactured and released on 31 july 2017.Expiration date: 2022-07-18.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implants revised: gmk-sphere 02.12.0210fl tibial insert fixed sphere flex #2/10 mm l, lot: 178736: (b)(4) items manufactured and released on 06 march 2018.Expiration date: 2023-02-20.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.1202l tibial tray fixed cemented # 2 l, lot: 177216: (b)(4) items manufactured and released on 27 february 2018.Expiration date: 2023-02-05.No anomalies found related to the issue.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: 176699: (b)(4) items manufactured and released on 01 march 2018.Expiration date: 2023-02-13.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 we were informed that the patient had come in due to signs of infection and the surgeon had removed all medacta hardware at an unknown date.The pathogen was confirmed as (b)(6).On (b)(6) 2018 the surgeon revised the spacer and implanted permanent hardware (5 months after the primary).

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8069024
• Report Number: 3005180920-2018-00906
• Device Sequence Number: 1658224
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/14/2018

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: 07/18/2022
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 171791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/14/2018
• 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