MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0410PSF
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 20 october 2017 the medical affairs performed a clinical evaluation and commented as follows: knee revision surgery is required 5,5 years after primary implantation.Radiographic images show the presence of a loosened insert fixation screw.This event may be due to insufficient tightening torque but the true cause cannot be determined.Immediate removal is strongly recommended.Batch review performed on 24 october 2017.Lot 120160: (b)(4) items manufactured and released on 29 march 2012.Expiration date: 2017-02-28.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 had backed out of the poly.The surgeon swapped the poly as planned, the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6983092
• Report Number: 3005180920-2017-00620
• Device Sequence Number: 13564122
• Product Code: JWH
• UDI-Device Identifier: 07630030817649
• UDI-Public: 07630030817649
• 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): 10/27/2017

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: 02/28/2017
• Device Catalogue Number: 02.07.0410PSF
• Device Lot Number: 120160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/27/2017
• 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