MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

Device Problem Degraded (1153)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due metallosis.In addition there was severe wear of the femoral head and the polyethylene liner.

Manufacturer Narrative

It was reported that a revision surgery was performed due metallosis.In addition there was severe wear of the femoral head and the polyethylene liner.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The potential root causes could included but are not limited to damaged product, implant corrosion or wear.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: R3 ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9490643
• MDR Text Key: 171888502
• Report Number: 1020279-2019-04484
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR