MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE1/10 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0110FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 march 2019.Lot 123205: (b)(4) items manufactured and released on 14-nov-2012.Expiration date: 2017-09-30.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: 4 years and 9 months after primary tkr the insert fixation screw got loose in the joint.It was immediately removed in an open revision surgery that also allowed articular surface inspection.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
Revision surgery performed due to inlay locking screw unscrewing 4 years and 9 months after primary.The inlay has been changed and the screw was not used during the revision.
Event or Problem Description
Information received on (b)(6) 2020: on (b)(6) 2020, the patient came in and is having the antibiotic spacer explanted and is having new hardware implanted.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE1/10 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8408118
• Report Number: 3005180920-2019-00138
• Device Sequence Number: 269066
• Product Code: JWH
• UDI-Device Identifier: 07630030825941
• UDI-Public: 07630030825941
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 09/30/2017
• Device Model Number: 02.12.0110FR
• Device Catalogue Number: 02.12.0110FR
• Device Lot Number: 123205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2019
• Supplement Date Received by Manufacturer: 02/09/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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: 56 YR