MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71306616
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a mom-thr surgery had been performed on (b)(6) 2004, the neck of the synergy porous femoral component sz 16 fractured.This adverse event was treated by a revision surgery on (b)(6) 2023.Patient's current health status is unknown.
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, as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.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 in adverse events in primary and revision surgery that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.Also, implant loosening or fracture, particularly of smaller sized or high offset implants, is more likely to occur in patients who are young, physically active, and/or heavy, which may lead to implant failure and 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 drawing, the final inspection includes the verification of part configuration per print.Also, material specification the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy 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.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, abnormal loading of limb, abnormal motion over time.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: SYN POR FEM COMP SZ 16
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 16379307
• Report Number: 1020279-2023-00336
• Device Sequence Number: 6327494
• Product Code: MRA
• UDI-Device Identifier: 03596010194503
• UDI-Public: 03596010194503
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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 Expiration Date: 04/17/2010
• Device Model Number: 71306616
• Device Catalogue Number: 71306616
• Device Lot Number: 00202542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2000
• 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: 68 YR
• Patient Sex: Unknown