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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI MED INSERT TRIAL SZ 5-6 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JRNY II UNI MED INSERT TRIAL SZ 5-6 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 74036040
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Event Description
It was reported that during inspection a jrny ii uni med insert trial sz 5-6 10mm was found cracked.No case involved; therefore, no patient was involved.
 
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 complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable, damage may occur during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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
JRNY II UNI MED INSERT TRIAL SZ 5-6 10MM
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 Key11742456
MDR Text Key247932368
Report Number1020279-2021-03618
Device Sequence Number1
Product Code HSX
UDI-Device Identifier00885556691588
UDI-Public00885556691588
Combination Product (y/n)N
PMA/PMN Number
K190085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/27/2021
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 Number74036040
Device Catalogue Number74036040
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received04/28/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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