MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number 71330001

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 02/26/2020

Event Type  Injury  

Event Description

It was reported that the patient had bilateral synergy stems with reflection cups, poly liners and ceramic heads since 1998.Right hip revised in 2018 with multiple surgeries and infection.Now left hip pain presenting over the gt area.Upon examination, liner wear was noted and osteolysis proximal femur and posterior acetabulum (xrays attached).Revision surgery was performed to leave the cup in situ if stable, exchange liner and head and pack the proximal femur with graft.Intraoperatively the cup and stem were stable and there was enough gt to suffice grafting.58mm reflection poly liner (20 degrees with 28mm id) was explanted numbers and some wear was noted on the inner part of the liner.

Manufacturer Narrative

The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: it was reported that this pt with bilateral tha implanted in 1998 underwent a lt revision due to pain over the lt greater trochanter area and upon exam, liner wear was noted and osteolysis proximal femur and posterior acetabulum.The cup and stem remain implanted.It was communicated that consent has not been granted for the patient¿s clinical/medical records to be released and included in this assessment.A medical doctor reviewed the x-ray and noted that there appears to be some osteolytic cyst in the greater trochanter region around the femoral stem.(unsure if looser subsidence on the single image provided) there also appears to be some shifting of the femoral head anteriorly within the liner which may indicate liner wear.The image confirms the reported findings but no indication can be made on the root cause of the wear beyond the 20 yrs of use.A thorough clinical assessment can¿t be performed and the patient impact beyond the revision surgery cannot be concluded.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP-DUMMY IMPLANT
• Type of Device: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9781908
• MDR Text Key: 181916205
• Report Number: 1020279-2020-00764
• Device Sequence Number: 1
• Product Code: JWH
• 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,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71330001
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 02/26/2020
• Supplement Dates FDA Received: 06/17/2020; 11/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention