MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKN02100106

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Perforation (2001)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that on literature review "comparison of the efficacy of artificial femoral head replacement and intertan internal fixation system in the treatment of elderly femoral intertrochanteric fractures," 2 patients suffered from a screw cutting-out after a primary internal fixation with a trigen intertan system.Those patients required nail removal.No further information is available.

Manufacturer Narrative

H10: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.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 devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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.Internal complaint reference number: case-2022-00098211-1.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW
• 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: 14053445
• MDR Text Key: 288877979
• Report Number: 1020279-2022-01591
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02100106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention