MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71352503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349); Metal Related Pathology (4530)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a total hip replacement construct had been implanted on the patient¿s right hip on (b)(6) 2013, the patient experienced pain, metallosis and elevated cobalt levels.A revision surgery was conducted on (b)(6) 2022 to treat this adverse event.During this procedure, the femoral head, acetabular liner, modular neck, and the femoral prosthesis were removed and replaced with a competitor¿s system.Intraoperatively, a blackened discoloration deep in the femoral end of the trunnion taper junction was noticed when the femoral neck was removed from the stem.An extended trochanteric osteotomy was necessary to remove the femoral component, during which a greater trochanter fracture occurred.There was a moderate bone loss of the proximal metaphysis of the femur as a result of stem removal given its complexity, as the implant was found to be completely ingrown distally.The patient was awoken from anesthesia and transferred to the recovery bed and taken to the recovery room in stable condition.Patient has been recovering well from the procedure, his cobalt levels have dropped to 1.1 and is able to ambulate without a cane or walker.
Additional Manufacturer Narrative
The device was not returned for evaluation but the reported event can be confirmed according with the clinical/medical findings.The clinical/medical investigation concluded that, the reported pain, elevated cobalt level and intraoperative findings of blackened discoloration deep in the female end of the trunnion-taper junction may be consistent with the reported metallosis.However, with information provided the clinical root cause of the reported reactions cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant or implant failure.Additionally, it is noted the greater trochanteric fracture occurred while the surgeon was extending the trochanteric osteotomy of a well fixated femoral component.It cannot be concluded the greater trochanteric fracture was associated with a mal performance of the implant or implant failure.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 that provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality and/or surgical technique.The contribution of the device to the reported event could not be corroborated.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 device was not returned for evaluation but the reported event can be confirmed according with the clinical/medical findings.The clinical/medical investigation concluded that, the reported pain, elevated cobalt level and intraoperative findings of blackened discoloration deep in the female end of the trunnion-taper junction may be consistent with the reported metallosis.However, with information provided the clinical root cause of the reported reactions cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant or implant failure.Additionally, it is noted the greater trochanteric fracture occurred while the surgeon was extending the trochanteric osteotomy of a well fixated femoral component.It cannot be concluded the greater trochanteric fracture was associated with a mal performance of the implant or implant failure.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 that provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, user/procedural variance and/or surgical technique.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
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the reported pain, elevated cobalt level and intraoperative findings of blackened discoloration deep in the female end of the trunnion-taper junction may be consistent with the reported metallosis.However, with information provided the clinical root cause of the reported reactions cannot be confirmed.Additionally, it is noted the greater trochanteric fracture occurred while the surgeon was extending the trochanteric osteotomy of a well fixated femoral component.It cannot be concluded the greater trochanteric fracture was associated with a mal performance of the implant or implant failure.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 18 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents was performed, and the total hip systems reveals in the adverse events in primary and revision surgery section that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.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 a similar event was identified.The following actions were taken: the occurrence rating was updated, the risk management plans were reviewed and updated, an improved in vitro fretting testing was stablished, the applicable surgical techniques were reviewed to include the instruction to "cleaning and drying before the impaction".Smf stems were obsoleted in the system.Containment actions were taken which prevented distribution of the product.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical assembly, abnormal motion over time, irregular implant interaction and neck selection.Corrective and preventive actions were previously initiated.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.H6 (health effect - clinical code, health effect - impact code, type of investigation, investigation findings).

• Brand Name: SMF STEM WITH STIKTITE SZ 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 15407847
• Report Number: 1020279-2022-04065
• Device Sequence Number: 5895432
• Product Code: LPH
• UDI-Device Identifier: 03596010619594
• UDI-Public: 03596010619594
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 71352503
• Device Catalogue Number: 71352503
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 08/04/2023; 01/31/2024
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/24/2022; 08/08/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0945-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN FEM HEAD MEMPHIS OX; UNKN R3 SHELL
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 111 KG