MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/12 MM RIGHT

Catalog Number	02.12.0212FR
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 30 june 2017 and includes: no torque limiting driver used in this case.On 21 july 2017 the (b)(4) performed a clinical evaluation based on the available pictures and commented as follows: radiologic images show the presence of a loosened insert fixation screw.This event may be caused by insufficient tightening torque but the real cause can't be determined.Immediate removal is strongly recommended.During revision surgery, visual inspection of articular surfaces can be performed in order to evaluate possible damages.No negative consequences should be expected for the insert fixation in absence of the safety screw.Batch review performed on 25 july 2017.Lot 150465: (b)(4) items manufactured and released on 08 september 2015.Expiration date: 2020-06-30.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.
Event or Problem Description
The patient came in complaining of discomfort.The surgeon took x-rays which revealed loose screw.The surgeon swapped the poly.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/12 MM RIGHT
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6740146
• Report Number: 3005180920-2017-00404
• Device Sequence Number: 10910275
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: 06/30/2020
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 150465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/25/2017
• 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