MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336456

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

It was reported that two liners continuously can't be implanted into the outer cup.The surgeon pushed too hard, resulting in the fracture of the posterior column of the acetabulum.After that, the outer cup of the acetabulum was replaced, and the biological acetabulum was fixed with bone cement.This was found during surgery.Procedure delayed over 30 minutes.Smith and nephew back up used.No pieces remain inside the patient.

Manufacturer Narrative

The associated reflection 3 hole shell and reflection xlpe liners were returned and evaluated.A lab analysis conducted during this investigation indicated that macroscopic examination of the shell revealed minor scuffs on the inner polished surface and on the rim, likely from attempted liner insertion.No significant damage was observed on the porous surface.Liner 1 showed scratches to the non-articulating surface and rim.Liner 2 showed scratches to the non-articulating surface, rim, slot and splines/scallops.The damage on both liners was likely caused by instruments during attempted placement.Dimensional evaluation performed on the cup noted all measured features were found to be within specification.Dimensional evaluation of the two liners noted both parts have visual damage on the inner diameter face, on the hood where the batch laser etch resides and on the bottom face.The outer diameter seems to be free of any significant damage.Based on cmm and overlay verification, spline profile and locking detail are oversized on both liners.All other mating dimensions are within spec.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.With the information currently available we are considering this to be an isolated event.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: REF THREE HOLE SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8296708
• MDR Text Key: 134727316
• Report Number: 1020279-2019-00367
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (y/n): N
• PMA/PMN Number: K960094
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71336456
• Device Lot Number: 14MMB0069A
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1