MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/14MM; TIBIAL INSERT FIXED

Model Number	02.07.0514PSF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 7 years and 8 months post primary the surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 january 2023: lot 136098: (b)(4) items manufactured and released on 12-feb-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional items involved in the event, batch review performed on 25 january 2023: gmk-primary 02.07.2204r femur ps cemented size 4 r (k090988) lot.132483 lot 132483: (b)(4) items manufactured and released on 10-jul-2013.Expiration date: 2018-05-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.150359 lot 150359: (b)(4) items manufactured and released on 04-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Gmk-primary 02.07.0035rp patella resurfacing size 3 (k090988) lot.148620 lot 148620: (b)(4) items manufactured and released on 05-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/14MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16395233
• Report Number: 3005180920-2023-00065
• Device Sequence Number: 20441314
• Product Code: JWH
• UDI-Device Identifier: 07630030818424
• UDI-Public: 07630030818424
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 12/31/2018
• Device Model Number: 02.07.0514PSF
• Device Catalogue Number: 02.07.0514PSF
• Device Lot Number: 136098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male