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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 41OD 26ID; PROSTHESIS,HIP,HEMI,TRUNNIONBEARING,FEMORAL
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SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 41OD 26ID; PROSTHESIS,HIP,HEMI,TRUNNIONBEARING,FEMORAL Back to Search Results
Catalog Number 71325041
Device Problem Unstable (1667)
Patient Problem Joint Dislocation (2374)
Event Date 08/16/2019
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to dislocation that caused by patient falling down.The liner and inner head were exchanged.
 
Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that several attempts have been made to obtain clinical/medical documents to support this complaint.It has been communicated that no information would be forth coming.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual devices involved our investigation cannot proceed.If the devices 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
TNDM BP SHL/XLPE LNR 41OD 26ID
Type of Device
PROSTHESIS,HIP,HEMI,TRUNNIONBEARING,FEMORAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9109269
MDR Text Key159774749
Report Number1020279-2019-03461
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 12/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71325041
Device Lot Number16GM01837
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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