MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +8; PROSTH, HIP, SEMI-CONST, METAL/CERAM/POL, CEMENTED OR NON-POROUS

Catalog Number 71342608

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 11/27/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed.Locking ring was disassembled with the bipolar cup in vivo.Bipolar cup and head were revised.

Manufacturer Narrative

The associated devices were returned and evaluated.A dimensional analysis of the locking ring measured 4 dimensions are out of specification; od, id, groove diameter and spherical radius id.The bi-polar construct was returned unassembled.Minor scratches observed on the articulating surface of the bi-polar component.The femoral head reveal significant scratching/wear through the oxide layer on the articulating surface and a few scratches on the chamfer, near the female taper.It¿s unclear if the scratches occurred during removal, transport, in vivo or during implantation.The head is too large to pass through the opening of the bi-polar/liner construct when stacked.The head would need to pass through the opening in order to disassemble.This demonstrated that the head diameter was large enough to be constrained with the bi-polar component as designed.No deformation was visible on the locking ring, however the lateral surface was scratched significantly and a few minor scratches occurred.No deviations of material or manufacturing process are indicated for these components.No conclusions as to the cause of this issue can be determined.A clinical evaluation was conducted and based on the product evaluation during the extraction the implant, the head was too large to pull through the locking ring opening, oversizing numerous features and particularly the through-hole diameter.This is relatively common for this product.The deviations described in the product analysis are most likely due to extraction damage, and not the fault of the smith and nephew device itself.The future impact to the patient cannot be determined.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: OXINIUM FEM HD 12/14 26 MM +8
• Type of Device: PROSTH, HIP, SEMI-CONST, METAL/CERAM/POL, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8192739
• MDR Text Key: 131298210
• Report Number: 1020279-2018-02881
• 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
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71342608
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention