MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 R

Model Number 02.09.2603R

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs director: a (b)(6) year old male patient had a revision tka with hinged device implanted 4 years ago.Now, reparation of the extensor mechanism is needed, probably to reposition the patella and muscles.This surgery is not caused by a problem with the existing tka.During surgery, it was noted that the internal post was partially unscrewed, although still functioning, and that the femoral component was partially loose.For these reasons, the devices were replaced with analogous new ones.We cannot predict what could have been the effect of leaving the implants in situ if the extensor mechanism had not required surgery.The root cause that originated the surgery of (b)(6) 2020 was not related to the implants used.The possibility that without this surgery the implants would have deteriorated exists, but cannot be quantified.Preliminary investigation performed by r&d knee manager: revision surgery of a gmk hinge implant due to repair of the extension apparatus after 4 years from primary implantation.During revision surgery, femoral component was found partially loosened with the stem partially disengaged due to unscrewing of the secure screw.It is not possible to assess if the damage of the extensor mechanism was caused by the partially loosening of the implant or had a different origin.Loosening of the implant could have led unexpected and unpredictable loading conditions on the system causing unscrewing of the stem screw.There is no evidence that loosening was related to a faulty device; different multiple factors, not implanted related, such as cement and cementation process, could have most likely played a role in the event.The lots of the implants involved in the event are unknown at the moment.

Event Description

Tka on the right knee, primary surgery on (b)(6) 2017 using medacta gmk hinge products, this surgery was already indicated for a revision as a loosening of the knee prosthesis.On (b)(6) during a surgery to repair the extension apparatus on the patient's right knee (the indication for this surgery was not for a knee revision) the surgeon noticed a metallosis and loosening on the femoral component.The post screw was a bit disengaged with the implant but still holding.The surgeon had to replaced with gmk revision product.

Manufacturer Narrative

On 15-jan-2021 we received information about lot numbers of the devices involved.On 25-jan-2021 we received also the devices phasically.Batch review performed on 15 january 2021.Gmk-hinge 02.09.2603r femoral component size 3 r lot.162148 lot 162148: 6 items manufactured and released on 12-may-2016.Expiration date: 2021-04-18.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event considering both reported problems.Visual inspection performed by r&d knee manager: revision surgery of a gmk hinge implant to repair the extensor apparatus after almost 4 years from primary surgery.During the revision procedure, the surgeon noticed a metallosis and that the femoral component and the post screw were loosened.From visual inspection, it is not possible to identify any possible reasons for femoral loosening.Cement is still adhering on the internal surfaces of the explanted component.It is possible that there was a lack of interdigitation between cement and bone.Reasons for lack of adhesion can be multifactorial (cementation procedure, temperature) not implant-related.Post screw disengaging can be a consequence of the femoral loosening.Hinge post screw, stem screw and tibial insert screw are not damaged.The femoral posterior augment is assembled to the component in a wrong way: it is cemented (not screwed) to the component and flipped upside-down.This shouldn't have played a role in the event.From images taken during the revision surgery, it seems that the femoral stem was not removed from the bone.We can suppose that the new implant was assembled with the femoral stem in place; this is not ideal for safety of the implant.It has not been reported whether or not a stem secure screw has been used.Additional item involved in the event, batch review performed on 15 january 2021 gmk-hinge 02.09.0317h fixed tibial insert size 3/17mm (k130299) lot.156544 lot 156544: 20 items manufactured and released on 02-feb-2016.Expiration date: 2021-01-19.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any other similar reported event.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 3 R
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11176319
• MDR Text Key: 227003529
• Report Number: 3005180920-2021-00039
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825446
• UDI-Public: 07630030825446
• Combination Product (y/n): N
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2021
• Device Model Number: 02.09.2603R
• Device Catalogue Number: 02.09.2603R
• Device Lot Number: 162148
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75