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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
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Event Description
It was reported that during inspection in warehouse the devices were found defectives.The tibial spacer block standar was noticed with an unspecific failure mode ((b)(4)).The journey femoral implant impactor bumper right ((b)(4)) was noticed broken.The journey ii bcs articular insert trial size 1-2 12 mm left ((b)(4)), universal insert spacer size 1-2 18 mm ((b)(4)), journey uni tibia trial insert size 3-4/ 8 mm ((b)(4)), universal insert spacer size 1-2 13 mm ((b)(4)) and journey uni tibia trial insert size 3-4/ 9 mm ((b)(4)) were noticed crack.
 
Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.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 complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
 
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Brand Name
JOURNEY UNI TIB TR INS SZ3-4/8MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11683500
MDR Text Key252290358
Report Number1020279-2021-03071
Device Sequence Number1
Product Code HSX
UDI-Device Identifier03596010588104
UDI-Public03596010588104
Combination Product (y/n)N
PMA/PMN Number
K113038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/05/2021
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
Device Operator Health Professional
Device Model Number71436133
Device Catalogue Number71436133
Device Lot Number20DM13185
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/23/2021
Initial Date FDA Received04/18/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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