MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN SEL POR SO 10/12 TPR SZ 12; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71305012

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a thr procedure had been performed on (b)(6) 2004, the patient experienced a stem neck fracture.This adverse event was addressed by revision surgery to explant the syn sel por so 10/12 tpr sz 12.The patient current health status is unknown.

Manufacturer Narrative

The device was not returned for evaluation but the pictures were reviewed, and the fracture device was confirmed.The clinical/medical investigation concluded that, without the requested clinically relevant supporting documentation, the root cause of the reported right stem neck fracture and subsequent revision cannot be confirmed.However, the photo imaging indicated possible impingement of the stem on the shell/liner but also cannot be confirmed as the damage to the liner could be from removal during the revision.The patient impact beyond the reported stem neck fracture and revision cannot be determined.The patient¿s current health status remains unknown as of the date of this assessment.Therefore, no further medical assessment can be rendered.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed 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 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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.The contribution of the device to the reported event could be corroborated since the device fractured, therefore, could not function as intended anymore.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 SEL POR SO 10/12 TPR SZ 12
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 14711096
• MDR Text Key: 294862392
• Report Number: 1020279-2022-03004
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71305012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 07/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REF THREE HOLE SHELL 60MM; REF XLPE 28 20 DEG 58-60 G; UNIV CAN ACET SCREW 15MM; UNIV CAN ACET SCREW 40MM; UNIV COCR 10/12 TAPER FEM HD 28MM +5 EXT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 63 KG