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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery will be scheduled since the head of tandem bipolar was dislocated.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-01800
• Device Sequence Number: 1337917
• Product Code: LZO
• UDI-Device Identifier: 03596010488916
• UDI-Public: 03596010488916
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2026
• Device Catalogue Number: 71342608
• Device Lot Number: 16GM05396
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 08/17/2018; 08/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/09/2018; 10/12/2018; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Other; Required Intervention