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

Device Problem Degraded (1153)

Patient Problem Injury (2348)

Event Date 01/09/2019

Event Type  Injury  

Event Description

It was reported that patient underwent a total hip replacement in 2003 the liner had eccentrically worn and the hip become unstable and a head and liner exchange was performed.No operative record was retrieved and after close visual inspection, the original product or lot number on the liner could not be identified.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, without the requested supporting clinical documents a thorough medical investigation cannot be rendered.Should information become available this complaint can be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• 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: 8297167
• MDR Text Key: 134740464
• Report Number: 1020279-2019-00370
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 180