MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 7 L

Model Number	02.12.0007L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 march 2020.Lot 173635: (b)(4) items manufactured and released on 10-nov-2017.Expiration date: 2022-10-19.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any other similar reported event.Other devices involved in the event gmk-sphere 02.07.0036rp patella resurfacing # 4 lot.184171 (k113571) batch review performed on 23 march 2020.Lot 184171: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-07-29.No anomalies found related to the problem.To date, 94 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1206l tibial tray fixed cemented # 6 l (k090988) batch review performed on 23 march 2020.Lot 182893: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-02.No anomalies found related to the problem.To date, 36 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0610crl tibial insert fixed sphere cr #6/10 mm l (k181635) batch review performed on 23 march 2020.Lot 182893: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-02.No anomalies found related to the problem.To date, 36 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection 1 year and 3 months after primary, the pathogen is unknown.The surgeon plans to remove all implants and implant an antibiotic spacer.More details will be provided once the surgery is complete.
Additional Manufacturer Narrative
On april 25th 2020 we have received the information that the pathogen is unknown and that the revision surgery was postponed, the date is still unknown.
Event or Problem Description
On (b)(6) 2020 we were informed that revision surgery has not been performed yet due to covid-19 concerns.Event description has been updated: the patient came in due to signs of an infection 1 year and 3 months after primary, the pathogen is unknown.The surgeon plans to remove all implants and implant an antibiotic spacer.Surgery has not been performed yet.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 7 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9932761
• Report Number: 3005180920-2020-00225
• Device Sequence Number: 19537406
• Product Code: JWH
• UDI-Device Identifier: 07630030825897
• UDI-Public: 07630030825897
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2020

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: No Information
• Device Expiration Date: 10/19/2022
• Device Model Number: 02.12.0007L
• Device Catalogue Number: 02.12.0007L
• Device Lot Number: 173635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 05/25/2020; 07/03/2020
• 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: Other