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

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.

• Brand Name: TANDEM UNI 12/14 TPR SLV + 0
• Type of Device: PROSTHESIS, 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 Key: 7627288
• MDR Text Key: 111972961
• Report Number: 1020279-2018-01170
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71326600
• Device Lot Number: 14JM14643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR