MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,

Model Number 71291302

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteolysis (2377)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, a patient had an emersion 13 stem primary ho implanted on (b)(6) 2009.However, the patient presented to hospital with pain in hip, and it was found that the emersion stem had snapped in half at the junction of the sleeve.Therefore, a revision surgery was performed on (b)(6) 2021.The old stem was removed through eto and osteotome blades, and a redapt stem was inserted.No operative reports available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the documentation imaging, the root cause of the reported stem fracture and subsequent revision could not be concluded; although, per the imaging, the distal cortical thickening with the mid-proximal lucency could indicate possible micro-motion of the component.The patient impact beyond the reported pain, noted gt fracture, stem fracture, and revision procedure with an eto could not be determined.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.The stem fractured approximately 75mm distally from the tip of the femoral trunnion.The proximal portion of the stem sleeve had areas of little bone on growth.This suggests that there was insufficient proximal support for the stem.This could have caused the stem to be subjected to fatigue loads that were above the fatigue strength of the material, which could eventually lead to fracture of the stem.Further examination of the distal end of the stem shows a region where its porous coated surface has been altered and is significantly smooth and there is pitting and scratching on the distal end of the stem/sleeve assembly.This may have been caused during extraction by a surgical instrument such as a chisel or osteotome blade.Examination of the cocr femoral head revealed a small scratch that may have been caused during extraction.Images of the fracture site on the proximal end of the stem/sleeve assembly show what appear to be stress fractures marking the possible origin of the stress fatigue failure beginning on the medial side of the implant and propagating across until complete failure approximately halfway through the diameter of the stem.No deviations from processing or material specifications were noted for any of the components.From visual observation and information provided, no conclusions can be made as to what initiated the fatigue fracture.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that based on the documentation imaging, the root cause of the reported stem fracture and subsequent revision could not be concluded; although, per the imaging, the distal cortical thickening with the mid-proximal lucency could indicate possible micro-motion of the component.The patient impact beyond the reported pain, noted gt fracture, stem fracture, and revision procedure with an eto could not be determined.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.H3, h6, h10.

• Brand Name: EMP 13 STEM PRIMARY HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11390906
• MDR Text Key: 233950611
• Report Number: 1020279-2021-01635
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2022

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 Model Number: 71291302
• Device Catalogue Number: 71291302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/28/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 06/15/2021; 01/07/2022
• Supplement Dates FDA Received: 03/29/2021; 07/07/2021; 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71335854/R3 42MM ID INTL COCR LINER 54MM/08CW15960
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male