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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US DELTA LINER 54MM OD; PRSTHSIS,HIP,SMI-CNSTRND,METAL/CRAMIC/CRAMIC/MTAL,CMNTDORUNCMNTD
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SMITH & NEPHEW, INC. R3 36MM ID US DELTA LINER 54MM OD; PRSTHSIS,HIP,SMI-CNSTRND,METAL/CRAMIC/CRAMIC/MTAL,CMNTDORUNCMNTD Back to Search Results
Catalog Number 71325154
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Type  Injury  
Event Description
It was reported that patient suffered a second dislocation after a primary left total hip "arhtroplasty".
 
Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
 
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Brand Name
R3 36MM ID US DELTA LINER 54MM OD
Type of Device
PRSTHSIS,HIP,SMI-CNSTRND,METAL/CRAMIC/CRAMIC/MTAL,CMNTDORUNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8196545
MDR Text Key131408762
Report Number1020279-2018-02894
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
PMA/PMN Number
P150030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71325154
Device Lot Number17FT88297
Date Manufacturer Received11/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age71 YR
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