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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT RT 7-8 10M; PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR
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SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT RT 7-8 10M; PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR Back to Search Results
Catalog Number 74029272
Device Problem Pitted (1460)
Patient Problem Injury (2348)
Event Date 05/05/2020
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed.The original operative plan was orif of tibia, but upon entering the capsule surgeon found signs of implant loosening due to septic/aseptic loosening.The surgeon noted oxinium on femur was fine, but surface of poly shows extreme pitting.
 
Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirm the stated failure mode.The articular surfaces of the device are heavily pitted from wear.The device was manufactured in 2013.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a traumatic injury.
 
Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirm the stated failure mode.The articular surfaces of the device are heavily pitted from wear.The device was manufactured in 2013.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a traumatic injury.
 
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Brand Name
JRNY II BCS CNSTRD ART ISRT RT 7-8 10M
Type of Device
PRSTHSS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10113891
MDR Text Key193600475
Report Number1020279-2020-01965
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00885556175262
UDI-Public885556175262
Combination Product (y/n)N
PMA/PMN Number
K140555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/16/2023
Device Catalogue Number74029272
Device Lot Number13GM12674
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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