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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHESIS, HIP, HMI-, TRUNNION-BERING, FEMRAL, METAL/POLYCETAL
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SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHESIS, HIP, HMI-, TRUNNION-BERING, FEMRAL, METAL/POLYCETAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 11/05/2019
Event Type  Injury  
Event Description
It was reported that during surgery, 28mm liner and 28mm oxinium head should have been revised for unknown reasons (initial surgery date was unknown.) the liner was explanted.There was a 30mins-1hours delay.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the liner was not explanted, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
HIP-DUMMY IMPLANT
Type of Device
PROSTHESIS, HIP, HMI-, TRUNNION-BERING, FEMRAL, METAL/POLYCETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9401411
MDR Text Key168801629
Report Number1020279-2019-04262
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,consum
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received12/03/2019
Supplement Dates Manufacturer Received12/05/2019
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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