MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STD 260MM BOW SZ 16 R; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71340516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a right tha revision surgery had been performed to implant an ech por std 260mm bow sz 16 r stem, it fractured on an unspecified date.A revision surgery was conducted on (b)(6) 2023 to address this event.The stem was exchanged for a zimmer wagner cone (305mm length) solution.Current patient's health status is unknown.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device was fractured into two separate pieces.The clinical/medical investigation concluded that, based on the information provided, the patient¿s significant surgical history, previous fractures and comorbidities could not be ruled out as contributing factors to the reported event.The stem fracture appears to have occurred near the previous periprosthetic fracture site and appear to be near where the proximal and distal plates abut.The instructions for use documents does address contraindications along with possible adverse events.The patient impact beyond the reported stem fracture with obvious angle variance, revision, and an anticipated post-operative course could not be determined.No further medical assessment can be rendered at this time.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 the adverse events that implant fracture is more likely to occur in patients who are young, physically active, and/or heavy, which may lead to implant failure and revision surgery.Moreover, the contraindications section revealed that in revision surgery, inadequate proximal implant support is contraindicated.There is an increased risk of implant failure in revision cases where proximal support is not achieved and poor bone quality exists.The lower the implant fixation point in the femur (distance from the head center) the greater the risk of implant fracture and/or re-revision.Also, the warnings and precautions section revealed that improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components.Besides, cutting, bending, or scratching the surface of components can significantly reduce the strength, fatigue resistance, and/or wear characteristics of the implant system.These may induce internal stresses that are not obvious to the eye and may lead to fracture of the component.Additionally, muscle looseness, malpositioning of components and/or failure to use the optimum-sized component may result in fracture of components.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 to the material specification, the quality and manufacture of the product material shall be controlled.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 patient anatomy, abnormal loading of limb, excessive forces and/or traumatic 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.

• Brand Name: ECH POR STD 260MM BOW SZ 16 R
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16877876
• Report Number: 1020279-2023-00988
• Device Sequence Number: 7291248
• Product Code: JDI
• UDI-Device Identifier: 03596010329073
• UDI-Public: 03596010329073
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 71340516
• Device Catalogue Number: 71340516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/06/2023
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG