MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0312PSF
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 08 september 2017 the medical affairs performed a clinical evaluation and commented as follows: five years after primary total knee arthroplasty, the insert fixation screw got loose in the joint.It was immediately removed, the polyethylene insert was exchanged and fixed with a new screw.During the revision surgery it was possible to assess the status of the articular surfaces and no damage was reported.No consequence should be expected from this event.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.Batch review performed on 11 september 2017.Lot 112544: (b)(4) items manufactured and released on 16 december 2011.Expiration date: 2016-09-30.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.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined that the screw backed out of the tibial insert.The surgeon washed out the knee, swapped the poly and explanted the screw.The surgeon used the screw with the new poly.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860923
• Report Number: 3005180920-2017-00515
• Device Sequence Number: 19010601
• Product Code: JWH
• UDI-Device Identifier: 07630030817168
• UDI-Public: 07630030817168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 02.07.0312PSF
• Device Lot Number: 112544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/13/2017
• 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: 69 YR