MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 15 STEM PRIMARY SO; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number	71291501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed to remove the femoral component due to gradual pain, disability and limb in left hip and leg.
Additional Manufacturer Narrative
The clinical/medical team concluded, the reported femoral stress reaction, mechanical issues and leg length discrepancy cannot be ruled out as potential contributing factors to the reported event.The surgeon¿s reported intra op findings of ¿cold welding of the modular femoral stem with a iight varus alignment and thinning of the anterior and lateral aspect of the subtrochanteric femoral bone stock¿ during revision could have contributed to the reported complaints of pain, disability and limp in left leg.It cannot be conclude the cause of the mechanical failure of the femoral component based on the information provided.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 parts revealed no prior complaints for the listed batches.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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on product evaluation if the device is returning.Proceed based on information provided by legal team and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) this is a 70-year-old male who underwent left total hip arthroplasty for hip dysplasia and reportedly developed gradual pain, disability and a limp.It was noted in the primary op-note ¿the femoral component was prepared with the referencing point now about 1 inch distal to the greater trochanter rather than the tip¿ due to the ¿markedly dysplastic hip¿.Revision left tha was performed approximately 3 years post primary due to mechanical failure (fretting, corrosion, and implant breakage) of the femoral component, proximal femoral stress reaction/¿thinning (per mri and bone scan), and left leg-length discrepancy.Due to legal restrictions no clinical radiographs are available for evaluation and/or inclusion in this medical investigation.Conclusion: the reported femoral stress reaction, mechanical issues and leg-length discrepancy cannot be ruled out as potential contributing factors to the reported event.The surgeon¿s reported intra-op findings of ¿cold welding of the modular femoral stem with a iight varus alignment and thinning of the anterior and lateral aspect of the subtrochanteric femoral bone stock¿ during revision could have contributed to the reported complaints of pain, disability and limp in left leg.It cannot be conclude the cause of the mechanical failure of the femoral component based on the information provided.Conclusion: the reported femoral stress reaction, mechanical issues and leg-length discrepancy cannot be ruled out as potential contributing factors to the reported event.The surgeon¿s reported intra-op findings of ¿cold welding of the modular femoral stem with a iight varus alignment and thinning of the anterior and lateral aspect of the subtrochanteric femoral bone stock¿ during revision could have contributed to the reported complaints of pain, disability and limp in left leg.It cannot be conclude the cause of the mechanical failure of the femoral component based on the information provided.
Event or Problem Description
It was reported that, after a left thr on (b)(6) 2015 patient presented pain and leg-length discrepancy, mri demonstrate mechanical failure of the femoral component.Patient underwent a revision surgery on (b)(6) 2018 where it was confirmed corrosion a femoral component breakage.All implants were removed.Patient outcome is unknown.

• Brand Name: EMP 15 STEM PRIMARY SO
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 8395263
• Report Number: 1020279-2019-00922
• Device Sequence Number: 16835552
• Product Code: MEH
• UDI-Device Identifier: 03596010561527
• UDI-Public: 03596010561527
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: 71291501
• Device Catalogue Number: 71291501
• Device Lot Number: 14CM10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 03/03/2021; 03/22/2021; 01/14/2022; 06/23/2022
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/16/2019; 03/09/2021; 03/24/2021; 01/19/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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: 71291674, EMP15 SLV MEDCONE1 SPOUTSLOT, 08KAB0009; 71330001 14EM05724; 71333334 15DM11598; 71336450 15AM01919; 71343204, OXINIUM FEMHD 12/1432MM+4, 15AM06040
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male