MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 40OD 26ID; PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRAMIC/PLYMR,CMNTDORNON-PORS,UNCMNT

Catalog Number 71342608

Device Problem Material Separation (1562)

Patient Problem Joint Dislocation (2374)

Event Date 08/17/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery will be scheduled since the head of tandem bipolar was dislocated.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A lab analysis conducted during this investigation noted that the damage was observed on the outer articulating surface of the femoral head and a gouge was observed on the inferior side of the head.This was likely caused by contact with the shell after the reported dislocation or during removal.In order for the head to dissociate with the shell/liner, it must pass through the poly locking ring.It was determined that the diameter of the femoral head was larger than the inner diameter of the locking ring by stacking the components.This suggests that femoral head was large enough to be locked in place by the poly locking ring, as designed.A supplemental evaluation of the head using sem/eds revealed elements of cobalt.Given the tandem shell component is made of cobalt chromium alloy, this is evidence of the head and shell coming into contact.A dimensional inspection was performed on the devices.Id bore of the tandem was verified as acceptable per the inspection criteria.The retaining ring measured within specification for all measured features.It is unknown if the ring was damaged during surgery.The damage/deformation at several features of the devices would not allow for accurate measurement.A clinical analaysis noted that based on the provided imaging, the root cause of the reported dislocation could not be determined.No material or manufacturing deviations were observed in this investigation.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TNDM BP SHL/XLPE LNR 40OD 26ID
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRAMIC/PLYMR,CMNTDORNON-PORS,UNCMNT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7869421
• MDR Text Key: 119980019
• Report Number: 1020279-2018-01800
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010488916
• UDI-Public: 03596010488916
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71342608
• Device Lot Number: 16GM05396
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Other; Required Intervention