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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 02/20/2020

Event Type  Injury  

Event Description

It was reported that the redapt cup was found to be loose.The patient underwent a tha in (b)(6) 2019 and has had several procedures ever since.The cup was removed along with liner and head.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, and the reported event could not be confirmed.A clinical analysis indicated that it was reported that the patient underwent a tha in (b)(6) 2019 and has had several procedures ever since.The redapt cup was found to be loose and the cup was removed along with liner and head.To date no medical/clinical documentation has been provided.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to fit/sizing, traumatic injury, abnormal motion over time, design of device, osteolysis, and poor ingrowth.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• 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: 9776481
• MDR Text Key: 181646479
• Report Number: 1020279-2020-00756
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention