MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that a revision surgery of a polar stem with a cocr head was performed due to taper corrosion.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical/medical team noted: three revisions were reported from the royal orthopaedic hospital in the united kingdom, secondary to cocr head with polarstem taper corrosion.No patient specific information has been provided to support these complaints.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Some potential probable causes of this event could include patient anatomy or a traumatic event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9440008
• MDR Text Key: 169920342
• Report Number: 1020279-2019-04330
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention