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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 74012419
Device Problems Crack (1135); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  malfunction  
Event Description
It was reported that during a tka, one (1) journey dcf ap fem cut blk 9 was found cracked and chipped.It no longer works.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
 
Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection of the returned device reveals the metal piece under the knob broke off.The broken piece was not returned with the device.The device exhibits significant signs of wear and usage.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
JOURNEY DCF AP FEM CUT BLK 9
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key17450432
MDR Text Key320299485
Report Number1020279-2023-01535
Device Sequence Number1
Product Code HRY
UDI-Device Identifier03596010556714
UDI-Public03596010556714
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number74012419
Device Lot Number18EM02176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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