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

Catalog Number	02.09.0212H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 21 july 2017 the medical affairs performed a clinical evaluation and commented as follows: four months after implantation, the screw that connects the femoral post extension to the femoral component was found to be broken.Radiographic images provided show the presence of a loosened screw.During revision surgery, visual inspection of the implant surfaces can be performed in order to verify the presence of damages.The reason of this failure could not be determined.This event had not taken place before.Such screw is normally tightened at 6nm and, if fully seated and correctly tightened, it is not subject to significant stresses, because it only acts as a supplement to conical fixation.Fracture analysis of the explanted fragment should be performed in order to understand better.To date, no explanation can be supplied.Batch review performed on 21 july 2017.Lot 151216: (b)(4) items manufactured and released on 15 october 2015.Expiration date: 2020-09-22.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
Revision due to gmk-hinge post screw breakage 4 months after primary surgery.Liner revised without difficulties, the broken screw head was accessible in front of the posterior boxes.Verification of all femoral and tibial parts.
Additional Manufacturer Narrative
On (b)(6) 2017 the r&d project manager performed a visual inspection of the retrieved components and commented as follows: hinge post screw: the hinge post secure screw is found not broken, as initially reported, but rather backed out from the hinge post.As we can see from the pre-op x-rays sent, the screw was found loosened in the joint after four months from implantation.The threaded part of the screw is damaged and plastically deformed.The screw has been plastically deformed once, backed out from the hinge post, was interposed between the femoral component and the tibia insert and underwent to the body load.Despite of this deformation, it is still possible to fix the screw into the hinge post.It is not possible to find an explanation for such an unlikely event.A torque limiting screwdriver (6 nm) is supplied and its use is mandatory in order to achieve the proper morse taper axial force.The only cause that we can suppose for this event is insufficient tightening torque, either due to a malfunction of the torque limiting device or to improper use.Tibia insert and its secure screw: the insert is damaged, plastically deformed with the central cone vocalized.This deformation was most likely due to the autoclave sterilization process after explantation.Hinge post: no elements relevant for the event can be noted on the hinge post and on its threaded hole.The medical affairs director performed a clinical evaluation of this case and commented as follows: four months after implantation, the screw that connects the femoral post extension to the femoral component was alleged to be broken.Radiographic images provided show the presence of a loosened screw.After former evaluation, the explant was received by the manufacturer and the detailed analysis revealed that the screw was not broken, only damaged.Therefore, this is a case of self-unscrewing.We have never obtained a similar result in the laboratory and one possible explanation is insufficient tightening torque, which would be surprising as a torque-limiting screwdriver was provided.Such device does not guarantee that the correct torque is applied, but it provides a distinct feedback when it is.The cause cannot be determined with certainty; no other potential causes can be listed to date.
Event or Problem Description
Revision due to alleged gmk-hinge post screw breakage 4 months after primary surgery.Liner revised without difficulties, the screw head was accessible in front of the posterior boxes.Verification of all femoral and tibial parts.At inspection, it was found that the screw was not broken, only damaged.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6731839
• Report Number: 3005180920-2017-00399
• Device Sequence Number: 16453001
• Product Code: KRO
• UDI-Device Identifier: 07630030825057
• UDI-Public: 07630030825057
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2020
• Device Catalogue Number: 02.09.0212H
• Device Lot Number: 151216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 72 YR
• Patient Weight: 79