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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP OPTIFIX SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. HIP OPTIFIX SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Degraded (1153)
Patient Problem Injury (2348)
Event Date 10/13/2018
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to wear and osteolysis.The primary operation was more than 25 years ago.Stem retained.Removed head, liner and optifix shell.
 
Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our clinical evaluation noted no additional clinical documents are available at this time.Therefore, no thorough clinical assessment of the reported issue can be rendered.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
 
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Brand Name
HIP OPTIFIX SHELL
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8051057
MDR Text Key126533838
Report Number1020279-2018-02414
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 03/13/2019
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received10/15/2018
Supplement Dates FDA Received03/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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