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

Catalog Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2018

Event Type  Injury  

Event Description

It was reported that after surgery, it was noticed that the set screw was moved in the nail.It was found in the x-ray.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and it was reported that after surgery, it was noticed that the set screw was moved in the nail.It was found in the x-ray.No revision surgery will be performed.Without the referenced x-ray we are unable to confirm the reported set screw migration.In addition, without the requested clinical relevant documents, x-rays or the explant a thorough medical assessment cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.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.No further actions are being taken at this time.

• Brand Name: HIP-DUMMY 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: 8266366
• MDR Text Key: 133719421
• Report Number: 1020279-2019-00226
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 12/25/2018
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1