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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +4MM MEDIUM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +4MM MEDIUM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71344248
Device Problem Insufficient Information (3190)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 01/30/2018
Event Type  Injury  
Event Description
It was reported that a surgical intervention was performed due to a subsided stem.The stem, the oxiniun modular head and the titanium modular head were removed.
 
Manufacturer Narrative
The affected titanium modular head sleeve was not returned for evaluation.A review of the manufacturing or product specifications for the listed batch did not reveal abnormalities that could have contributed to the reported issue.The device was manufactured in 2016.A review of complaint history for listed part revealed no prior complaints for this failure mode with the same batch number.Our clinical evaluation noted that based on the lack of clinical/medical information, the root cause of this patients ¿loosening/subsidence¿ cannot be concluded.The cause may have been as the physician suggested the cancer and chemo therapy.Should any relevant information become available this complaint can be re-assessed.Without the return of the actual product involved, 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 the device or additional information be received, the complaint will be reopened.
 
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Brand Name
TITANIUM MODULAR HEAD SLEEVE +4MM MEDIUM
Type of Device
PROSTHESIS, 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
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key7279382
MDR Text Key100388148
Report Number1020279-2018-00188
Device Sequence Number1
Product Code MBL
UDI-Device Identifier00885556022962
UDI-Public00885556022962
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/17/2018
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
Device Catalogue Number71344248
Device Lot Number16DT67802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2018
Initial Date FDA Received02/17/2018
Supplement Dates Manufacturer Received02/07/2018
02/07/2018
Supplement Dates FDA Received02/22/2018
04/17/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age74 YR
Patient Weight66
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