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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 11/08/2018

Event Type  Injury  

Event Description

It was reported that a patient who presents with groin, hip and thigh pain, was diagnosed with osteolysis around stem.A revision surgery was performed and the stem was removed with minimal force.Head and liner were also removed.Cup was left insitu and a suitable size liner was inserted.Dr decided to insert smith & nephew cpcs stem.

Manufacturer Narrative

The associated complaint device was not returned.A clinical analysis indicated that the x-rays provided support a loose femoral stem, which likely contribute to the reported left groin, thigh, and hip pain.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP STEM 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: 8128476
• MDR Text Key: 129170539
• Report Number: 1020279-2018-02671
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HIP FEMORAL HEAD IMPLANT/UNKNOWN; HIP LINER IMPLANT/UNKNOWN; HIP FEMORAL HEAD IMPLANT/UNKNOWN; HIP LINER IMPLANT/UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR