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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +0MM SHORT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +0MM SHORT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71344247
Device Problem High Test Results (2457)
Patient Problems Test Result (2695); Patch Test, Abnormal Results Of (3166)
Event Date 10/20/2017
Event Type  Injury  
Event Description
It was reported that patient presents increased titanium level due to titanium is present in implanted components. Titanium level 3. 64 (upper reference range per als (b)(6) ab is 2. 96).
 
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Brand NameTITANIUM MODULAR HEAD SLEEVE +0MM SHORT
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key8039640
MDR Text Key126179928
Report Number1020279-2018-02374
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/18/2021
Device Catalogue Number71344247
Device Lot Number11HT09597
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/18/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1
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