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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 0 PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

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SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 0 PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL Back to Search Results
Catalog Number 71326600
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 05/21/2018
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed to remove the unipolar head due to acetabular erosion. The unipolar sleeve was stuck to the anthology stem. The sleeve removal tool was tried, but the tool sheered off at the threads. A bone tamp was then used to try and remove the sleeve with no success. After approximately 30 minutes of trying to remove the sleeve with no success it was decided that the well affixed anthology stem needed to be removed. This took approximately an hour to remove. I was unable to find a lot number on the anthology stem, as well as the unipolar sleeve. The removed implants were retained by the hospital.
 
Manufacturer Narrative
The associated complaint device was not returned. A clinical analysis indicated that based on the information provided, the root cause of the acetabular protrusion and subsequent conversion to left tha is likely disease progression. The inability to remove the sleeve from the well-fixed anthology stem via alternative means as well as the re-use removal tool which fractured were the contributing factors to the stem removal. The patient impact beyond the reported clinical symptoms, surgical extension, and l hip revision/conversion to tha with an extensive osteotomy and intraoperative complications cannot be determined. No further medical assessment is warranted at this time. A review of complaint history did not reveal additional complaints for the listed batch. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. Without the actual product involved and/or device information, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
 
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Brand NameTANDEM UNI 12/14 TPR SLV + 0
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
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 Key7627288
MDR Text Key111972961
Report Number1020279-2018-01170
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K896580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71326600
Device Lot Number14JM14643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
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