MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Discomfort (2330); Muscle/Tendon Damage (4532)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, after a tka surgery was performed on a patient's left knee on (b)(6) 2016, another tka had been performed on the patient's right knee on (b)(6) 2020.As soon as he woke up from his surgery, he felt a violent burning on the side of his right tight.The surgeon attributed this burning sensation to a cut made in a muscle during surgery.During the 18 months that followed, the patient experienced a chronic pain and felt a twisting in his right leg that was causing a chronic inflammation in his ankle when walking.He reported that even driving causes him an "electric shock" sensation when his foot goes from the accelerator to the brake.Pain is mostly experienced in tension and less in compression movements.Patient reported that his orthopedist didn't find a solution to his problems.After custom orthotics in new shoes, kinesiologist, osteopath, chiropractor, inversion table, a.R.T., injections, among other treatments, patient still have no improvement.He tried searching for additional medical help, and a knee scan with and without plantar orthosis was performed on (b)(6) 2023, which demonstrated 8 abnormal mechanical markers out of 15.An ultrasound performed on (b)(6) 2023 revealed a black, diseased semi-membranosus tendon, which the physiatrist stated in his report: "it is possible that a post- prosthetic alignment disorder with his right foot in external rotation increases the tension on his semi-membranosus and could cause this problem to persist over time".On (b)(6) 2023, an orthopedist carried out manual examinations which led to perform x-rays and a "lower limb assessment/goniometry" to the patient.Doctor dissected the images and determined that the slight asymmetries compared vertically do not explain the external rotation of the right foot.However, in the background, a greater difference appeared when comparing the distances between the 2 fibulas and their respective neighboring prostheses.On the left side, the fibula appears completely.While on the right side, the fibula is hidden behind the prosthesis, indicating rotation of the latter.From here the doctor understood the ultrasound previously performed; namely how the semimembranosus was too close to the prosthesis.His experience then made him suspect a rotation of the tibial plateau of the prosthesis.It was recommended to perform a special ct protocol to measure the abnormal rotation of the tibial plateau of the prosthesis.From this study it was determined that the tibial plate a (tibial baseplate + articular insert) of the right knee prosthesis would have been fixed to the tibia in internal rotation instead of being centered.Once mated, the femoral portion of the prosthesis forces the tibia into opposite rotation, rotating the foot outward.The right foot turned outwards causes chronic inflammation of the right ankle, an imbalance of the right hip and the lower right back.

Event Description

It was reported that, after a tka surgery was performed on a patient's left knee on (b)(6) 2016, another tka had been performed on the patient's right knee on (b)(6) 2020.As soon as he woke up from his surgery, he felt a violent burning on the side of his right tight.The surgeon attributed this burning sensation to a cut made in a muscle during surgery.During the 18 months that followed, the patient experienced a chronic pain and felt a twisting in his right leg that was causing a chronic inflammation in his ankle when walking.He reported that even driving causes him an "electric shock" sensation when his foot goes from the accelerator to the brake.Pain is mostly experienced in tension and less in compression movements.Patient reported that his orthopedist didn't find a solution to his problems.After custom orthotics in new shoes, kinesiologist, osteopath, chiropractor, inversion table, a.R.T., injections, among other treatments, patient still have no improvement.He tried searching for additional medical help, and a knee scan with and without plantar orthosis was performed on (b)(6) 2023, which demonstrated 8 abnormal mechanical markers out of 15.An ultrasound performed on (b)(6) 2023 revealed a black, diseased semi-membranosus tendon, which the physiatrist stated in his report: "it is possible that a post- prosthetic alignment disorder with his right foot in external rotation increases the tension on his semi-membranosus and could cause this problem to persist over time".On (b)(6) 2023, an orthopedist carried out manual examinations which led to perform x-rays and a "lower limb assessment/goniometry" to the patient.Doctor dissected the images and determined that the slight asymmetries compared vertically do not explain the external rotation of the right foot.However, in the background, a greater difference appeared when comparing the distances between the 2 fibulas and their respective neighboring prostheses.On the left side, the fibula appears completely.While on the right side, the fibula is hidden behind the prosthesis, indicating rotation of the latter.From here the doctor understood the ultrasound previously performed; namely how the semimembranosus was too close to the prosthesis.His experience then made him suspect a rotation of the tibial plateau of the prosthesis.It was recommended to perform a special ct protocol to measure the abnormal rotation of the tibial plateau of the prosthesis.From this study it was determined that the tibial plate a (tibial baseplate + articular insert) of the right knee prosthesis would have been fixed to the tibia in internal rotation instead of being centered.Once mated, the femoral portion of the prosthesis forces the tibia into opposite rotation, rotating the foot outward.The right foot turned outwards causes chronic inflammation of the right ankle, an imbalance of the right hip and the lower right back.

Manufacturer Narrative

H2: additional information ¿b5¿.H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation.The clinical/medical investigation concluded that, based on the patient provided information an abnormal rotation of the tibial plateau of the prosthesis possibly caused the right foot to turn outwards causing chronic inflammation of the right ankle, an imbalance of the right hip and the lower right back.However, this cannot be confirmed as the event is ongoing and has not been addressed.Additionally, we cannot rule out the implant selection, bone quality or the patient¿s activity level as a contributory factor.It is unknown if the instruction for use for knee systems was adhered to.Therefore, it cannot be concluded that the reported adverse event is related to a mal performance of the implant or implant failure.However, based on the information provided, the unsatisfactory experience could be confirmed.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions review could not be performed.The instructions for use for knee systems does warn that the patient should be warned of surgical risks and made aware of possible adverse effects and that the implant can break or become damaged as a result of strenuous activity or trauma.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN JOURNEY / JOURNEY II KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18728610
• MDR Text Key: 335715776
• Report Number: 1020279-2024-00387
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG