MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE LINER; PE TIBIAL INSERT

Catalog Number	02.12.0411FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018 it was added that: the agent stated that the liner was intact and still in place.He also stated that the femur was stable and that it was cemented in flexion during the primary.On (b)(6) 2018 it was added that only the insert was revised, other components were in good conditions.On (b)(6) 2018 the medical affairs manager checked the x-rays commenting: 3 years after primary tkr the insert fixation screw got loose in the joint.It was immediately removed and polyethylene liner was exchanged.Femoral component articular surface can be visually inspected during surgery and no damage was reported in an area of marginal or negligible bearing, therefore little or no further consequence should be expected from this event.The cause for self-unscrewing of the insert fixation screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.Batch review performed on (b)(6) 2018, lot 141418, 75 items manufactured and released on 06 may 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, 65 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to instability caused by the screw backing out of the poly.The torque limiting driver was not used in the primary surgery.The surgeon revised the poly and the surgery was completed successfully.

• Brand Name: GMK SPHERE LINER
• Common Device Name: PE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8208001
• Report Number: 3005180920-2018-01045
• Device Sequence Number: 1670066
• 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: 2015
• 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): 01/02/2019

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: 03/21/2019
• Device Catalogue Number: 02.12.0411FL
• Device Lot Number: 141418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/02/2019
• 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