MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/10MM

Catalog Number	02.09.0310H
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gmk-hinge fixed tibial insert size 3/10 mm (reference 02.09.0310h) is not registered in us.In particular, all sizes of gmk-hinge fixed tibial inserts 10 mm are not registered and marketed in the us.Nevertheless, this event is being reported to fda since all sizes of the gmk-hinge fixed tibial inserts thicknesses 12-14-17-20-23-26 mm are registered and marketed in the us and the event involves the screw, that is the same for sizes and thicknesses of the subject insert.Batch review performed on 13 july 2017.(b)(4).
Event or Problem Description
Revision surgery 16 months after primary due to breakage of the screw.The screw was loose in the joint.Surgeon removed the screw and replaced the inlay, without a screw.The surgeon was not quite happy with the solution, he did not want to make a tibia change.
Additional Manufacturer Narrative
On 14 jul 2017 the medical affairs (b)(4) made the following analysis: radiographic images provided show the presence of a broken insert fixation screw 1 year after primary surgery.The reason of this failure is not known.It is conceivable that in a case with very high instability the screw was forced to withstand high stresses, beyond the design parameters, because the anatomic structures were not contributing.Immediate removal of the screw is strongly recommended.Visual inspection of the articular surfaces can be made during revision and any damage can be assessed.The surgeon decided to replace only the polyethylene insert.On 17 july 2017 the r&d project manager added the following comments: radiographic images provided show the presence of a loosened insert fixation screw 16 months after primary surgery.The picture taken from explanted screw shows that it was broken, but gives no indications about appearance of fracture , furthermore the screw is not being returned to manufacturer.The reason of this failure may be due to an improper tightening torque applied during surgery, but this cannot be demonstrated.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6714026
• Report Number: 3005180920-2017-00379
• Device Sequence Number: 10955511
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 02.09.0310H
• Device Lot Number: 151218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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: 74 YR
• Patient Weight: 80