MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; PROSTHETIC HIP JOINT

Device Problems Fracture (1260); Mechanical Problem (1384); Naturally Worn (2988)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/23/2016

Event Type  Injury  

Event Description

Patient who lives in (b)(6) only part of the year ((b)(6) the remainder) began experiencing increases right hip pain.She previously had a hip replacement several years ago.She presented to an outside hospital.Radiographs performed at the outside hospital revealed a fracture of the femoral stem which was not present on previous films.Surgery was planned at the outside hospital; however, given the complexity of the surgery they felt transfer to a larger facility was better.Therefore, the patient was prepped for revision of the femoral stem and possible revision of the acetabular component.Intraoperative fluid was sent for analysis.Results were consistent with absence of infection so mechanical failure of the implant was suspected.In addition, there was significant polyethylene wear.The acetabular component itself was lightly retroverted and stability was not possible.Therefore, a revision of the acetabulum was performed as well.The implant was found to be fractured as anticipated.But with difficulty, the femoral stem was removed requiring an extended trochanteric osteotomy to facilitate removal.Stable reconstruction with a tapered revision stem, as well as revision of the acetabulum allowed excellent stability even prior to closing the osteotomy including flexion 90 degrees, addition 10 degrees, internal rotation of 80 degrees, and no posterior instability.There was no anterior instability with maximal extension and external rotation.What was the original intended procedure? - right total hip arthroplasty (2009 in (b)(6)) - revision, right totally hip arthroplasty, acetabular, and femoral components including extended trochanteric device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Type of Device: PROSTHETIC HIP JOINT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 5966130
• MDR Text Key: 55374889
• Report Number: 5966130
• Device Sequence Number: 0
• Product Code: KWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2016
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PT WHO LIVES IN (B)(6) ONLY PART OF THE YEAR (
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91