MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200103

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/01/2018

Event Type  Injury  

Event Description

On the literature article named "effect of nighttime total knee arthroplasty on prognosis", it was reported that, 9 patients from the daytime group developed deep vein thrombosis after the tkr surgery.It was not reported if/how the adverse event was treated.The outcome of the patient is unknown.

Manufacturer Narrative

H3, h6: the devices, used in treatment, were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, the article was provided in a non-english/non-translated format and was translated via transperfect.It was reported that the requested clinical information/documentation was not mentioned in the article and this was verified post translation.Without patient-specific clinical information/documentation, further assessment of the reported dvt could not be performed.The root cause beyond those reported in the article could not be confirmed or concluded; however, the article reported that the incidence of dvt differences in the night-time (2) versus daytime procedures (7) was not significant.The patient impact beyond the reported dvt could not be determined.The current patient status is unknown.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 GENESIS II TOTAL KNEE FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12075828
• MDR Text Key: 258649165
• Report Number: 1020279-2021-05455
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other