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

Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9490643
• Report Number: 1020279-2019-04484
• Device Sequence Number: 3336202
• Product Code: JDL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 05/20/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR