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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GNS II CMT TIB SIZE 6 {} LEFT; PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER

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SMITH AND NEPHEW, INC. GNS II CMT TIB SIZE 6 {} LEFT; PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER Back to Search Results
Catalog Number 71420170
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Information (3190)
Event Date 07/03/2018
Event Type  Injury  
Manufacturer Narrative
Occupation: attorney.
 
Event Description
It was reported that the patient underwent a revision surgery due to stiffness.
 
Manufacturer Narrative
The associated genesis ii resurfacing patellar component, genesis ii oxinium femoral component, genesis ii tibial baseplate and legion cr high flexion insert were not returned for evaluation.A clinical analysis noted that without the explant, physical therapy records, or radiographs, the information provided is insufficient to determine the root cause of left knee stiffness.However, the healing process of the procedure implanting the smith and nephew device, poor rehab, or inflammatory cannot be ruled out and not due to the smith and nephew device itself.In addition, the reported of the patient¿s fall as well as the patient¿s body habitus cannot be ruled out as possible contributing factors.The patients¿ left knee flexion improved from 0-70 prior to the revision to about 0-110° post revision.The future impact to the patient beyond the revision cannot be determined.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
GNS II CMT TIB SIZE 6 {} LEFT
Type of Device
PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
1450 brooks road
memphis, tennessee
memphis 38116
MDR Report Key7924075
MDR Text Key122255949
Report Number1020279-2018-01902
Device Sequence Number1
Product Code JWH
UDI-Device Identifier03596010206282
UDI-Public03596010206282
Combination Product (y/n)N
PMA/PMN Number
K951987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/05/2019
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 No Information
Device Expiration Date07/03/2017
Device Catalogue Number71420170
Device Lot Number15KM03838
Initial Date Manufacturer Received 09/05/2018
Initial Date FDA Received10/01/2018
Supplement Dates Manufacturer Received09/05/2018
Supplement Dates FDA Received04/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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