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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X 54-56 0 DG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. REF LNR 28X 54-56 0 DG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71740854
Device Problem Material Integrity Problem (2978)
Patient Problem Injury (2348)
Event Date 08/20/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to poly wear.Implant was originally placed in 1996.Liner and head were removed and replaced.
 
Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided ,this complaint will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
REF LNR 28X 54-56 0 DG SZ F
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9068753
MDR Text Key158626895
Report Number1020279-2019-03375
Device Sequence Number1
Product Code LPH
UDI-Device Identifier03596010231932
UDI-Public03596010231932
Combination Product (y/n)N
PMA/PMN Number
K932755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71740854
Date Manufacturer Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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