MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R

Catalog Number	02.12.0610FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2018; lot 144657: (b)(4) items manufactured and released on 18 november 2014.Expiration date: 2019-09-30; 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 12 july 2018: two years after primary total knee replacement, insert fixation screw was found loose.Immediate removal is strongly recommended.During surgery, articular surfaces can be visually inspected in order to evaluate possible damages.No negative consequence should be expected for the absence of the insert fixation screw in the future life of the implant.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
During a standard follow-up check in the hospital, the surgeon detected the loose tibial insert fixation screw in the back of the joint on the corresponding x-ray pictures.A torque-limiter screwdriver was not available at the date of the primary surgery.Currently we have no further information about the next step in terms of revision surgery date.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7722400
• Report Number: 3005180920-2018-00551
• Device Sequence Number: 13713217
• Product Code: JWH
• UDI-Device Identifier: 07630030826948
• UDI-Public: 07630030826948
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: 09/30/2019
• Device Catalogue Number: 02.12.0610FR
• Device Lot Number: 144657
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/26/2018
• 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
• Patient Age: 71 YR