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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-02881
• Device Sequence Number: 13928244
• Product Code: LZO
• UDI-Device Identifier: 03596010488916
• UDI-Public: 03596010488916
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/03/2019

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 Catalogue Number: 71342608
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention