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

Model Number OR45-DUMMY2

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to loosening of the stem.

Manufacturer Narrative

The associated complaint device was not returned.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.Without the actual product involved and/ or product information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• 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: 8918773
• MDR Text Key: 155168401
• Report Number: 1020279-2019-03107
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OR45-DUMMY2
• Device Catalogue Number: OR45-DUMMY2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1