MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L

Catalog Number	02.12.0411FL
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 may 2018; lot 142498: (b)(4) items manufactured and released on 10 september 2014.Expiration date: 2022-02-13; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 03 may 2018: 1,5 years after primary tka the insert fixation screw got loose in the joint.Immediate removal is strongly recommended.No consequence should be expected for the absence of the screw in the future life of the implant.During reoperation, articular surfaces must be visually checked to avoid damage to the femoral component.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the screw backed out of the sphere poly.The torque driver was not used in the primary surgery.The surgeon revise the screw on (b)(6) 2018.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7483274
• Report Number: 3005180920-2018-00293
• Device Sequence Number: 1630384
• Product Code: JWH
• UDI-Device Identifier: 07630030862601
• UDI-Public: 07630030862601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: 02/13/2022
• Device Catalogue Number: 02.12.0411FL
• Device Lot Number: 142498
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 05/03/2018
• 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