MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP STEM 9 SO 140MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	71290902
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Radiolucent Lines (4848)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that after undergoing a total hip replacement (thr) in 2014 due to unknown reasons patient suffered breakage of an emperion stem.This adverse event was addressed by conducting a revision surgery on (b)(6) 2023, during which the emp stem 9 so 140mm, head and liner were exchanged.During procedure, they encountered significant sclerosis on the distal aspect of the sleeve, so a decision was made to start preparing a trochanteric osteotomy.However, there had already been a small crack in the lateral aspect of the greater trochanter.Patient was on toe touch weightbearing.She had strict abductor precautions for six to twelve weeks which depended on the four week postoperative x-ray.In addition, seven weeks post-op patient showed alignment and appearance of the hardware unchanged and without acute osseous complication.
Additional Manufacturer Narrative
H3,h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the x-ray provided appear to confirm the stated failure mode of stem component fracture.The definitive clinical root cause of the emperion modular hip stem fracture cannot be definitively concluded.However, based on the x-ray findings that are radiolucent lines on either side of the stem and osteolysis surrounding the cup we cannot rule out micro-motion/loosening as the likely cause of the stem fracture.It is uncertain if the revision finding of the "small crack in the lateral aspect of the greater trochanter" occurred intra-operatively or prior to the revision.The impact to the patient beyond the implant fracture, the revision and weight bearing restrictions cannot be determined since additional follow-up visits are anticipated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems revealed that implant fracture has been identified in adverse events in primary and revision surgery section as a probable cause of patients who are young, physically active, and/or heavy.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 the inspection procedure, the final inspection includes the verification of part configuration per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.
Additional Manufacturer Narrative
B5: describe event or problem, b7: other relevant history, including preexisting medical conditions: b3: date of event.
Event or Problem Description
It was reported that after undergoing a total hip replacement (thr) in (b)(6) 2024 due to osteoarthritis the patient suffered breakage of an emperion stem.This adverse event was addressed by conducting a revision surgery on (b)(6) 2023, during which the emp stem 9 so 140mm, head and liner were exchanged.During procedure, they encountered significant sclerosis on the distal aspect of the sleeve, so a decision was made to start preparing a trochanteric osteotomy.However, there had already been a small crack in the lateral aspect of the greater trochanter.Patient was on toe touch weightbearing.She had strict abductor precautions for six to twelve weeks which depended on the four week postoperative x-ray.In addition, seven weeks post-op patient showed alignment and appearance of the hardware unchanged and without acute osseous complication.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the x-ray provided appear to confirm the stated failure mode of stem component fracture and there are radiolucent lines on either side of the stem, cortical thickening of the femur and osteolysis surrounding the cup on x-ray which indicates there may have been loosening of the stem and micromotion but cannot be confirmed.Post revision image shows bilateral total hip replacements are present, revised on the right and with 6 femoral cables, with anatomic alignment and without periprosthetic fracture.Based on the findings in the primary operative report, the patient¿s excessive anteversion of 40 degrees, and the surgeon¿s decision to use a size 9 emperion stem cannot be ruled out as likely contributing to the fracture.In addition to the x-ray findings that show radiolucent lines on either side of the stem and osteolysis surrounding the cup we cannot rule out micro-motion/loosening as the likely cause of the stem fracture.It is uncertain if the revision finding of the "small crack in the lateral aspect of the greater trochanter" occurred intra-operatively or prior to the revision.The impact to the patient beyond the implant fracture, the revision and weight bearing restrictions cannot be determined since additional follow-up visits are anticipated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that implant fracture has been identified in adverse events in primary and revision surgery section as a probable cause of patients who are young, physically active, and/or heavy.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 the inspection procedure, the final inspection includes the verification of part configuration per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or injury.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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The implanted stem components and the femoral head were examined visually and with a digital microscope.No destructive testing was performed.No deviations from processing or material specifications were noted for any of the components.The fracture of the stem occurred approximately 45 mm from the trunnion to the fracture site.Scratches along the surface of the proximal end of the stem are present that could have been introduced during extraction.The proximal portion of the stem sleeve had some evidence of bony attachment.Digital microscopy images suggest a possible stress fatigue fracture began on the outer surface of the stem that propagated through the cross section of the stem until it fractured completely in shear.The oxinium femoral head showed no signs of wear or scratches except for a small region on the diameter of the head which was possibly caused by extraction.From visual observation and information provided, it is likely that the lack of fixation along the distal length of the femoral stem led to the initiation of the fatigue fracture toward the proximal end due to micro motion within the stem sleeve.The clinical/medical investigation concluded that the x-ray provided also confirms the stated failure mode of stem component fracture and there are radiolucent lines on either side of the stem, cortical thickening of the femur and osteolysis surrounding the cup on x-ray which indicates there may have been loosening of the stem and micromotion.Post revision image shows bilateral total hip replacements are present, revised on the right and with 6 femoral cables, with anatomic alignment and without periprosthetic fracture.Based on the findings in the primary operative report, the patient¿s excessive anteversion of 40 degrees, and the surgeon¿s decision to use a size 9 emperion stem cannot be ruled out as likely contributing to the fracture.In addition to the x-ray findings that show radiolucent lines on either side of the stem and osteolysis surrounding the cup we cannot rule out micro-motion/loosening as the likely cause of the stem fracture.It is uncertain if the revision finding of the "small crack in the lateral aspect of the greater trochanter" occurred intra-operatively or prior to the revision.The impact to the patient beyond the implant fracture, the revision and weight bearing restrictions cannot be determined since additional follow-up visits are anticipated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that implant fracture has been identified in adverse events in primary and revision surgery section as a probable cause of patients who are young, physically active, and/or heavy.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 the inspection procedure, the final inspection includes the verification of part configuration per print.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EMP STEM 9 SO 140MM
• 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: 20076040
• Report Number: 1020279-2024-01674
• Device Sequence Number: 2962990
• Product Code: MEH
• UDI-Device Identifier: 03596010561275
• UDI-Public: 3596010561275
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2022
• Device Catalogue Number: 71290902
• Device Lot Number: 12JM04949
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/26/2024; 12/18/2024; 07/01/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024; 11/28/2024; 12/20/2024; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMP SLV 9 MD CONE 2 SPOUT, LOT#: 09BAB0035A.; OXINIUM FEM HD 12/14 32MM +0, LOT#: 13MM10364.; R3 0 DEG XLPE ACET LNR 32MM X 48MM, LOT#: 14AM14230.; R3 0 HOLE ACET SHELL 48MM, LOT#: 13MM06271.; REF THREADED HOLE COVER, LOT#: 13MM00033.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female