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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP KIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP KIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number V0100109
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  Injury  
Event Description
It was reported that, during a tka surgery, it was found that the cutting guides from a vis adpt guide lgnp kit were not properly manufactured.After cuts were made, the leg alignment was off.The issue was fixed via standard instrumentation, and no surgical delay was reported.Patient was not injured beyond the reported problem.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the surgeon complained the blocks were not properly manufactured and after cuts, the leg alignment was off.Reportedly, ¿the issue was fixed via standard instrumentation and no harm was done to the patient¿.It was communicated that the requested documentation was not available, and the hospital discarded block after use.The clinical root cause of the reported events cannot be definitively concluded.No further patient impact would be anticipated as reportedly ¿the issue was fixed via standard instrumentation¿ without patient harm or surgical delay.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.An engineering evaluation was performed and could not confirm a root cause for the stated failure mode.All checks were found to be within visionaire standards.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported event could not be corroborated.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.Corrected data: h6 (health effect - impact code).
 
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Brand Name
VIS ADPT GUIDE LGNP KIT
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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 Key12953486
MDR Text Key281861715
Report Number1020279-2021-08547
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00885556656396
UDI-Public00885556656396
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/22/2022
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 Expiration Date03/28/2022
Device Model NumberV0100109
Device Catalogue NumberV0100109
Device Lot Number00213842V1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/07/2021
Supplement Dates Manufacturer Received07/21/2022
Supplement Dates FDA Received07/22/2022
Date Device Manufactured09/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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