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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ3-4/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ3-4/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71436133
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/27/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event or Problem Description
It was reported that, a nail prox drop had a connecting issue and the other reported devices were cracked or broken.As this was noticed upon field inspection, there was not patient involvement.
 
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Brand Name
JOURNEY UNI TIB TR INS SZ3-4/8MM
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12488754
Report Number1020279-2021-06963
Device Sequence Number3392225
Product Code HSX
UDI-Device Identifier03596010588104
UDI-Public03596010588104
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K113038
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number71436133
Device Catalogue Number71436133
Device Lot Number19HB00369
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/27/2021
Supplement Date Received by Manufacturer10/11/2021
Initial Report FDA Received Date09/17/2021
Supplement Report FDA Received Date10/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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