MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP

Catalog Number UNKNOWN

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Loss of Range of Motion (2032)

Event Date 06/20/2008

Event Type  Injury  

Event Description

On the literature article named "use of mid-vastus approach in less invasive primary total knee arthroplasty", it was reported that, after a genesis ii system had been implanted, 1 patient required manipulation because of stiffness (rom, 0 degrees - 80 degrees).After that, the knee acquired 125 degree flexion.The nature of the manipulation was not specified within the paper.

Manufacturer Narrative

D3, g3, h2, h3 and h6; the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the requested information is not available.Without the requested patient-specific clinical information/documentation, further assessment of the reported events cannot be provided, and the root cause beyond those reported in the article could not be concluded.The patient impact beyond the reported events cannot be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.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.D4: update part and lot number.G2: update report source.

• Brand Name: UNKN GENESIS II TOTAL KNEE FEM COMP
• Type of Device: UNKN GENESIS II TOTAL KNEE FEM COMP
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11800024
• MDR Text Key: 249797390
• Report Number: 1020279-2021-03931
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• 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: 07/15/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention