MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPECTRON EF FEM COMP 135MM LARGE; SPECTRON PRIMARY

Catalog Number 129002

Device Problem Device Slipped (1584)

Patient Problem Osteolysis (2377)

Event Date 04/20/2015

Event Type  Injury  

Event Description

It was reported that a revision was performed due to aseptic loosening/osteolysis.

Manufacturer Narrative

Manufacturer Narrative

The associated devices were returned and evaluated.Visual inspection of the returned devices showed scratches on the stem likely sustained during removal of the device.Bone ongrowth was observed on the acetabular shell that appeared well adhered as it did not become dislodged with the application of manual force.Scratches inside the acetabular shell were observed.Deformation to the taper mouth of the femoral head were observed, which was also likely caused due to removal of the device.The polyethylene liner showed damage along the rim likely from removal, and showed it also showed discoloration likely due to lipid absorption.The polyethylene liner showed burnishing and signs of tunnel wear within the articulating region, which is consistent with the reported complaint of osteolysis.The screw showed deformation just below the head likely due to contact with the acetabular liner.No material or manufacturing deviations were observed during this investigation.No clinical supporting documentation has been provided with this case.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SPECTRON EF FEM COMP 135MM LARGE
• Type of Device: SPECTRON PRIMARY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 4756870
• MDR Text Key: 5788314
• Report Number: 1020279-2015-00250
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129002
• Device Lot Number: 41009026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 740054/50813259
• Patient Outcome(s): Hospitalization; Required Intervention