MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0510CRL TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM L

Model Number	02.12.0510CRL
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 october 2021: lot 2002130: (b)(4) items manufactured and released on 05-june-2020.Expiration date: 2025-june-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: few weeks after primary cemented tka the pe liner disengages from the tibial baseplate during lateral motion of the patient.According to report, the surgeon refers to have properly clipped the liner to the baseplate at primary surgery.The substitution operation has been carried out and there is no further adverse event to be expected.We do not recognize a clinical cause for this event.No further conclusion can be drawn with the information at hand.Other device involved: batch review performed on 3 november 2021.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2009490: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-nov-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting discomfort and instability after doing lateral motions at work.X-ray's confirmed the poly was disengaged from the tibia tray.About 3 months and a half, the surgeon revised the poly and the surgery was completed successfully.The insert was properly engaged in the primary surgery and the clipping noise was heard.

• Brand Name: GMK-SPHERE 02.12.0510CRL TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM L
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12868143
• Report Number: 3005180920-2021-00900
• Device Sequence Number: 11689461
• Product Code: JWH
• UDI-Device Identifier: 07630040707619
• UDI-Public: 07630040707619
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/24/2021

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: 06/06/2025
• Device Model Number: 02.12.0510CRL
• Device Catalogue Number: 02.12.0510CRL
• Device Lot Number: 2002130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2020
• 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: Other
• Patient Sex: Male