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

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 06/20/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a fall.Patient presented pain and x-rays indicated a fractured ceramic liner.Cup and head were removed.

Manufacturer Narrative

It was reported that a revision surgery was performed due to a fall.Patient presented pain and x-rays indicated a fractured ceramic liner.Cup and head were removed.The associated devices were not returned for evaluation.Therefore a product analysis could not be performed.As device details were not provided, therefore, device history record and complaint history review cannot be conducted.Our investigation including a clinical analysis noted that patient presented pain and x-rays indicated a fractured ceramic liner.No relevant supporting clinical information will be provided.The patient's current condition is unknown.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• 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: 8766151
• MDR Text Key: 150240874
• Report Number: 1020279-2019-02651
• 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
• Report Date: 10/15/2019

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/07/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention