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

Catalog Number	71336456
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8296708
• Report Number: 1020279-2019-00367
• Device Sequence Number: 1912510
• Product Code: MBL
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: 71336456
• Device Lot Number: 14MMB0069A
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1