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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

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SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER Back to Search Results
Model Number 74025636
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, while setting up for a tka, the inner sterile package of a jrny ii cr isrt xlpe rt sz 3-4 15mm was discovered to be unsealed.As this was noticed upon set-up/inspection, there was no patient involvement.Surgery was performed, without any delay, with a back-up device instead.
 
Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the outer packaging was open.As the inner pouch was not received to fully evaluate the complaint, a thorough investigation could not be rendered.The device was inside of the opened outer sterile barrier pouch and no inner sterile barrier pouch.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.The packaging sequence was reviewed.The steps in the procedure include placing the product in the inner pouch, followed by sealing it.The product then is placed in the outer pouch and sealed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include damage during shipping, mishandling or a user error.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 for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
JRNY II CR ISRT XLPE RT SZ 3-4 15MM
Type of Device
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
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 Key16039074
MDR Text Key308279358
Report Number1020279-2022-05018
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/13/2023
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 Expiration Date05/13/2024
Device Model Number74025636
Device Catalogue Number74025636
Device Lot Number14EM13083
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received02/10/2023
Supplement Dates FDA Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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