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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNKN01200301
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 06/23/2021
Event Type  Injury  
Event Description
It was reported that after tka surgery on 2008 on left knee, a revision surgery will be performed to the patient because the tip of the bcs tibial post broke off.However the operation day will depend on the availability of the implants in the country.
 
Manufacturer Narrative
H3, 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, per complaint details, a left insert revision was performed due to breakage of the bcs post approximately 12-13 years post tka in a 110kg patient.It was communicated that the requested clinical documentation was not available.Based on the information provided, the root cause of the reported event could not be fully assessed, and a definitive conclusion could not be established.Patient impact beyond the reported breakage and subsequent revision could not be determined, as the patient was reportedly "healthy".No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.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 for this event could include but not limited to traumatic injury or surgical technique.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.
 
Manufacturer Narrative
(b)(4).B4: event description updated.
 
Event Description
It was reported that after tka surgery on 2008 on left knee, the device had the tip of the bcs tibial post broke off and had a revision surgery on (b)(6) 2021.The patient outcome is unknown.
 
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Brand Name
UNKN JOURNEY / JOURNEY II KNEE IMPL
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 Key12129310
MDR Text Key260294542
Report Number1020279-2021-05773
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKN01200301
Was Device Available for Evaluation? No
Date Manufacturer Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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