MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/17 MM L

Catalog Number	02.12.0117FL
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018; lot 132004: (b)(4) items manufactured and released on 09 july 2013.Expiration date: 2018-05-31; 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; 1 year and 2 months after total knee replacement insert fixation screw backed out of the polyethylene insert.Immediate screw removal is strongly recommended.During arthroscopic surgery, visual inspection of articular surfaces can be performed in order to evaluate possible damages.No consequence should be expected for the absence of the 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
Unscrewing of the locking screw.Revision surgery planned for (b)(4) 2018.
Additional Manufacturer Narrative
On 30 july 2018 we were informed that the surgeon revised the liner.The surgery was completed successfully on (b)(6) 2018.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/17 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7706394
• Report Number: 3005180920-2018-00522
• Device Sequence Number: 13794303
• Product Code: JWH
• UDI-Device Identifier: 07630030826054
• UDI-Public: 07630030826054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 05/31/2018
• Device Catalogue Number: 02.12.0117FL
• Device Lot Number: 132004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: 70 YR