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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC UNKNOWN SMITH AND NEPHEW SHELL IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC UNKNOWN SMITH AND NEPHEW SHELL IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/08/2019
Event Type  Injury  
Event Description
It was reported a suspected septic loosening of prosthesis.Prosthesis was removed and patient placed on traction for three weeks.
 
Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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.We consider this investigation closed.
 
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Brand Name
UNKNOWN SMITH AND NEPHEW SHELL IMPLANT
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC
1450 brooks road
TN 38116
MDR Report Key8405794
MDR Text Key138298371
Report Number1020279-2019-01005
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received02/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN LINER; UNKNOWN SCREWS; UNKNOWN LINER; UNKNOWN SCREWS
Patient Outcome(s) Hospitalization; Required Intervention;
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