MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	71291102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr revision surgery was performed on (b)(6) 2015 , it was identified that the emp 11 stem primary ho was fractured at the stem/neck junction on (b)(6) 2022.This event was treated with a revision surgery on (b)(6) 2022.Patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device was fractured.Also, the clinical/medical investigation concluded that, the provided x-ray and photos were reviewed and confirm the reported emperion stem implant breakage at the stem/neck junction.However, as of the date of this medical investigation, supporting clinical documentation has not been provided.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision cannot be determined with the limited information provided.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in adverse events that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance and/or involuntary muscular disorders increase the risk of cracking or fracture of implant components, which may lead to revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with inspection procedure, the final inspection includes the verification of part configuration per print, it should also verify that the part is free of damaged areas.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EMP 11 STEM PRIMARY HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 15740872
• Report Number: 1020279-2022-04708
• Device Sequence Number: 6363986
• Product Code: MEH
• UDI-Device Identifier: 03596010561381
• UDI-Public: 03596010561381
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71291102
• Device Catalogue Number: 71291102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female