MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP11 SLV LG CONE 3 SPOUT SLOT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS

Catalog Number ASKU

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 07/25/2018

Event Type  Injury  

Event Description

It was reported that dr.(b)(6) at hss revised an emperion implant for a fractured stem.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, based on the available information the root cause of the breakage cannot be concluded though stress fatigue due micromotion is the common cause of failure for this sort of breakage.It is unknown what type of daily exercise the patient participated in, also unknown if the adduction position of the crossed legs, while putting on his socks contributed to the issue.No report on the patient's current status has been provided.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.We consider this investigation closed.Credit cannot be issued for the device.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.The lab analysis concluded, bone on-growth was observed on the porous coating on the sleeve indicating proximal fixation into the femur.It appears that the sleeve was gouged on all sides in order to remove it from the patient during explant.The stem fractured near the proximal region of the sleeve.Fretting/corrosion were observed on the distal & proximal portion of the stem where the sleeve attaches, as well as gouges and scratches on the distal flutes of the stem.Scratches observed on the proximal stem neck region, near the driver hole, likely due to the removal process or contact with the fractured surface.Fretting was observed on the lateral face of the stem, near the fracture.Radial lines occurred on the lateral side of the fractured surfaces of the proximal & distal portions of the stem.Observed scratches that breached the oxide layer on all articulating surfaces of the oxinium femoral head.It is unclear when these scratches may have occurred; prior to explant, during removal process, or during transportation after removal.Xlpe liner was returned with scratches on the lateral rim/face and a large gouge on the proximal od, between the locking mechanism and the anti-rotational tabs.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.The clinical/medical team concluded, the clinical information provided, of the corrosion of the trunnion, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause for second revision was the stem fracture.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A lab analysis was conducted and confirms bone on-growth was observed on the porous coating on the sleeve indicating proximal fixation into the femur.It appears that the sleeve was gouged on all sides in order to remove it from the patient during explant.The stem fractured near the proximal region of the sleeve, as seen in figures 1&2.Fretting/corrosion were observed on the distal & proximal portion of the stem where the sleeve attaches, as well as gouges and scratches on the distal flutes of the stem.Gouges were likely caused during extraction.Scratches observed on the proximal stem neck region, near the driver hole, likely due to the removal process or contact with the fractured surface.Fretting was observed on the lateral face of the stem, near the fracture.Radial lines occurred on the lateral side of the fractured surfaces of the proximal and distal portions of the stem.The fretting and the lateral radial lines on the distal and proximal fractured surfaces indicate that the fracture likely initiated on the lateral aspect of the stem.Observed scratches that breached the oxide layer on all articulating surfaces of the the oxinium femoral head, shown in.It is unclear when these scratches may have occurred; prior to explant, during removal process, or during transportation after removal.Xlpe liner was returned with scratches on the lateral rim/face and a large gouge on the proximal od, between the locking mechanism and the anti-rotational tabs.No defects in the manufacturing of the devices, materials, or designs were noted during this visual analysis.A clinical evaluation was conducted and confirms the clinical information provided, of the corrosion of the trunnion, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause for second revision was the stem fracture.What in turn cause the stem to break cannot be concluded and was not revealed by the product analysis.It cannot be concluded that the combination of 3rd party components with the smith & nephew components didn¿t contributed to the issue.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: EMP11 SLV LG CONE 3 SPOUT SLOT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7807147
• MDR Text Key: 117955016
• Report Number: 1020279-2018-01603
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2020

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
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 07/25/2018; 04/07/2020
• Supplement Dates FDA Received: 10/05/2018; 10/19/2019; 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention