MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R

Catalog Number	02.12.0514FR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2018: lot 143399: (b)(4) items manufactured and released on 29 august 2014.Expiration date: 2019-06-30.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 "evalutation" performed by medical affairs director on november 16, 2018: 2 years after primary cemented tkr the insert fixation screw got loose in the joint.It was immediately removed and insert was exchanged.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.Preliminary investigation performed by r&d product manager november 21, 2018: "loosened" of the insert safety screw occurred about 2 years after primary surgery.Screw backed out and was found loosened in the joint.Tibial insert and screw have been removed during revision surgery.Head and threaded part of the screw looks partially damaged.They have been plastically pressed once, backed out from the inlay, were interposed between the femoral component and the tibia insert and underwent to the body load.Articular surface of the insert is damaged, with "sctratches" and the negative footprint of the screw.Tibial baseplate and femoral components have not been explanted, so we can suppose that they have been found in good condition.The most-likely cause for self-unscrewing of the screw after few months from implantation, was insufficient tightening torque.Using a screwdriver provided with a torque limitation would prevent this event.Torque limiter screwdriver is already available and its use is mandatory.But other unknown factors might also play a role in the event.
Event or Problem Description
About 1 year and 10 months after primary the surgeon revised the patient for inlay fixation screw unscrewing.Liner swap.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 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: 8099793
• Report Number: 3005180920-2018-00945
• Device Sequence Number: 16652868
• Product Code: JWH
• UDI-Device Identifier: 07630030826825
• UDI-Public: 07630030826825
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 06/30/2019
• Device Catalogue Number: 02.12.0514FR
• Device Lot Number: 143399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/23/2018
• 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