MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 56MM; ULTRASOUND, SINUS

Catalog Number	71336456
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision sugery was performed due to damaged liner.Liner and cup were removed.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the damage and exposure of the zr2.5nb substrate were observed on the femoral head.The acetabular liner exhibited a fracture around roughly 50% for the liner rim.The rim fragment was returned.Additional damage opposite the rim fragment was observed, which was likely due to impingement with the femoral stem neck.Dark discoloration, possibly caused by deposits of metallic debris from the damage head were observed on the face of the poly liner.Yellowish discoloration, likely caused by absorption of biological fluid observed on the backside of the liner.Faint witness of screw hole patterns could be seen.The porous bead coating on of the metal shell revealed burnished areas indicating potential movement of the shell against the acetabular bone.The clinical/medical team concluded, based on the available information the root cause for the components damage cannot be concluded but impingement and/or edge loading cannot be ruled out.However, as the implantation date is not known and no clinical/medical documents were provided, the age of the prosthesis and/or trauma or over use cannot be ruled out. no information on the current status of the patient has been forthcoming.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the parts revealed no prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.Credit will not be issued for the devices.

• Brand Name: REF THREE HOLE SHELL 56MM
• Common Device Name: ULTRASOUND, SINUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7562941
• Report Number: 1020279-2018-01024
• Device Sequence Number: 11257591
• Product Code: LWI
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: 08/10/2022
• Device Catalogue Number: 71336456
• Device Lot Number: 12HM06527
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: Required Intervention; Disability
• Patient Age: 80 YR