MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMPERION STEM 9 PRIMARY; PROSTHE,HIP,SEMICONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CALICUMPHOSPHATE

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 02/25/2019

Event Type  Injury  

Event Description

It was reported that implant fractured at the head-neck junction of the emperion stem.No medical intervention has not yet been reported.

Event Description

It was reported that implant fractured at the head-neck junction of the emperion stem.

Manufacturer Narrative

The devices, used in treatment, were returned for evaluation.A lab analysis confirmed metal transfer markings on the liner indicating impingement with the femoral, and the head; potentially from particles at the impingement site suggesting migration.The metal shell was not returned.No visual indication the liner/head played a role in the fracture of the neck.The stem/ sleeve assembly indications well fixation.On-growth material and scratches/ scoring likely occurred during removal.The femoral neck fracture initiated on the lateral side and prorogating toward the medial side; found a notch on the lateral neck.The cause for this fracture is potentially the result of overload to the stem cross section at the fracture location.The circumstances leading to the overload cannot be established from information that has been provided.A clinical analysis indicated that only 1 x-ray showing the fracture was provided.Without supporting clinical/medical documents a thorough investigation cannot be performed.A review of the device history records for the listed batch did not reveal any deviations.At this time, we have no reason to suspect that the product 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 for any necessary corrective actions.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Potential probable causes that could contribute to the reported event have been identified in the risk management file, as fatigue corrosion overload, and fretting/corrosion at the modular junctions chemical reactions with body fluids.The need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EMPERION STEM 9 PRIMARY
• Type of Device: PROSTHE,HIP,SEMICONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8436863
• MDR Text Key: 139338222
• Report Number: 1020279-2019-01127
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K052426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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: Health Professional
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 02/26/2019; 02/23/2020
• Supplement Dates FDA Received: 03/25/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD UNKNOWN PART / UNKNOWN LOT NUMBER; LINER 71331748/ 08GT21776; PART NO.: 71290923 / LOT NO.: 06BAB001; PART NO.: 71325172 / LOT NO.: 500087; PART NO.: 71331748 / LOT NO.: 08GT21776
• Patient Outcome(s): Hospitalization; Required Intervention