MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBIAL BASE LM/RL SZ 5; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422425

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/05/2020

Event Type  Injury  

Event Description

It was reported that the patient presented a longitudinal periprosthetic fracture of the medial tibial condyle, starting from the medial fin.An osteosynthesis with screws was performed to correct this problem.Implants remained in situ.

Manufacturer Narrative

Results of investigation: it was reported that the patient presented a longitudinal periprosthetic fracture of the medial tibial condyle, starting from the medial fin.An osteosynthesis with screws was performed to correct this problem.Implants remained in situ.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch 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.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.A medical analysis noted that the 3-week post-op images appear to show a fracture extending through the medial fin cut.This could have possibly weakened the tibia and increasing its susceptibility to fracture if the cut extended too far.Review of the 5 days post op image do not show an extended cut.The surgical intervention/osteosynthesis was directly related to the periprosthetic fracture.The patient impact beyond the reported fracture and subsequent osteosynthesis could not be determined.No further medical assessment can be rendered 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 not limited to traumatic injury or surgical technique used.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBIAL BASE LM/RL SZ 5
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9831057
• MDR Text Key: 183328888
• Report Number: 1020279-2020-00871
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422425
• Device Lot Number: 18GM18561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 103