MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/17 MM; KNEE TIBIAL INSERT

Model Number	02.12.0317FL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-december-2020: lot#: 154739: 60 items manufactured and released on 15-jan-2016.Expiration date: 02-jan-2021.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta r&d knee project manager: two months after revision surgery, in which a thicker tibial insert was implanted due to instability, during routine check the insert fixation screw was found loose in the knee joint.According to the x-rays provided, the screw is located in the posterior side of the knee joint, in a not bearing region.The images provided suggest that the screw is probably broken, more consideration can be done only if the screw would be removed.Although the torque limiter screwdriver has been reported to be used at the time of the revision surgery, the post-op x-rays show that the screw was not well-sited as expected.The reason of the failure may be the improper tightening of the screw, but other unknown conditions may also play a role.No consequence should be expected for the absence of the screw in the future life of the insert.Clinical evaluation performed by medacta medical affairs director: few weeks after insert revision surgery due to instability, the insert fixation screw got loose in the joint.It's probably not the whole screw, because it looks broken.According to the image provided, the screw is in a non bearing region, however, removal is strongly recommended.No consequence should be expected for the absence of the screw in the future life of the implant.In case of no, or minimal damage to the articular surface, little, or no further consequence should be expected from this event.
Event or Problem Description
During a follow-up visit, it was discovered that the inlay locking screw is unscrewed, and free into the joint.After a more specific analysis, the screw results to be broken.There is no plan to revise the patient, at the moment, nor to remove the part of the screw.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/17 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11036712
• Report Number: 3005180920-2020-00941
• Device Sequence Number: 11089632
• Product Code: JWH
• UDI-Device Identifier: 07630030826450
• UDI-Public: 07630030826450
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/18/2020

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: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: 02.12.0317FL
• Device Catalogue Number: 02.12.0317FL
• Device Lot Number: 154739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/18/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75