MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PF IMPLANT MED LT; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71461014

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Synovitis (2094); Subluxation (4525); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 05/25/2020

Event Type  Injury  

Event Description

It was reported that in revision surgery the left knee shows a transverse fracture, not radiologically visible.After that, it could be seen that the replacement (femoral metal shield) has a chipped metal fragment.Further information is being requested.

Event Description

It was reported that in revision surgery the left knee shows a transverse fracture, not radiologically visible.After that, it could be seen that the replacement (femoral metal shield) has a chipped metal fragment.Further information about this case was requested to the hospital but no answer was received.Investigation was completed with information available.

Manufacturer Narrative

Results of investigation: it was reported that in revision surgery the left knee shows a transverse fracture, not radiologically visible.After that, it could be seen that the replacement (femoral metal shield) has a chipped metal fragment.The associated journey pfj oxinium trochelear component, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of risk management files and the instructions for use found that the reported failure is documented appropriately and occurrence is within the expected level.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to traumatic injury, improper alignment or size of device used.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

Our reference number: (b)(4).

Event Description

It was reported that the patient underwent a revision surgery of the left knee on (b)(6) 2020.The revision surgery was performed due to a transverse fracture of the pfj component.A massive abrasion of the pfj and metal debris was found, a complete synovectomy was performed.The pfj component got broken in two parts, the removal of the femoropatellar component along with cement residues were also removed from the area of the femur and the patella.A patella modelling was then performed until a flat surface was achieved, without the further loss of bone substance.The patient outcome is unknown.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical investigation concluded that based on the documentation provided, the root cause of the reported events was multifactorial, including the years since the 2/2014 x-ray identified left knee joint collapse and disease progression, as well as the reported ¿2x patella luxation¿ in the past 1.5 years prior to the revision, the noted varus misalignment, and deposition of polyethylene and metallic wear particles in the presence of multiple comorbidities and obesity permagna.However, the component fracture was not apparent in the imaging provided and the clinical root cause of the breakage could not be definitively concluded.The product evaluation remains pending at the time of this medical investigation.The assessed patient impact was the reported increased knee complaints/persistent pain, luxation x2, intraop findings, and the revision/conversion to tka.No further medical assessment can be rendered at this time.Should additional clinical documentation and/or product evaluation results become available in the future, the clinical/medical task may be re-evaluated.The lab analysis concluded that damage, characterized by a transverse fracture, was observed on the journey pfj.Bone cement remained attached to the fixation surface of the journey pfj.Damage and scratches were observed on the articular and fixation surfaces of the journey pfj.Damage and deformation was also observed on the patella which was returned fractured in several pieces.No material or manufacturing deviations were observed in this investigation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.Based on this investigation, the need for corrective action is not indicated.Should 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: JOURNEY PF IMPLANT MED LT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10174836
• MDR Text Key: 195762231
• Report Number: 1020279-2020-02611
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 03596010544216
• UDI-Public: 03596010544216
• Combination Product (y/n): N
• PMA/PMN Number: K051086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 71461014
• Device Catalogue Number: 71461014
• Device Lot Number: 10HM10726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71420570,10HM14208,GNS II BICONVEX PAT 29MM
• Patient Outcome(s): Hospitalization; Required Intervention