MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE OFFSET CONNECTOR 3 MM

Catalog Number	02.07.0003
Health Effect - Clinical Codes	Failure of Implant (1924); Test Result (2695)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation based on the pictures of the explanted components performed by r&d product manager on 20 july 2018: revision surgery due to breakage of the femoral offset connector 3mm after 3 years and 8 months from primary surgery.From the picture of the explanted components, it can be seen that the offset connector is broken in correspondence to the tapered connection with the femoral component.Metallosis is present in the synovial capsule.Residual cement is present in the distal surface of the tibial component and internal surface of the femoral component.It is not possible to determine any possible causes for breakage in a such an unlikely event.We can only suppose that some unexpected clinical conditions of the patient occurred after surgery, could have led to excessive and unpredictable loads acting on the implant and causing its breakage.Other factors, not identifiable, could have played a role.Explanted components have been asked to be returned in order to have the possibility to further investigate the broken part and the nature of the breakage.Unfortunately, it has been already confirmed that the explanted implants are not available to be returned.Clinical evaluation performed by medical affairs (b)(4) on 23 july 2018; less than 4 years after revision tka with intramedullary stems on both femoral and tibial side, the connection of the offset connector of the femoral stem broke off and revision was required.One known condition that may lead to this kind of fracture is malalignment: this highly-constrained knees, often implanted in very poor quality bones, may be subject to extreme stresses.No radiographs were made available to evaluate if anomalous bone support was present at the time of fracture.There is no mention of a traumatic event, nor it is excluded.The explants are not being returned.The information at hand does not allow a thorough investigation on this case.Batch review performed on 26 july 2018: lot 145742: (b)(4) items manufactured and released on 17 september 2014.Expiration date: 2019-07-31.No anomalies found related to the issue.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The surgeon revised a patient due to offset connector breakage and consequent metallosis.During the procedure femur and tibial components were found mobilized.

• Brand Name: GMK-HINGE OFFSET CONNECTOR 3 MM
• Common Device Name: OFFSET CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7726663
• Report Number: 3005180920-2018-00566
• Device Sequence Number: 904110
• Product Code: JWH
• UDI-Device Identifier: 07630030815577
• UDI-Public: 07630030815577
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 07/31/2019
• Device Catalogue Number: 02.07.0003
• Device Lot Number: 145742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/27/2018
• 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