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 Problem Perforation (2001)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4)."comparison of the effects of three intramedullary fixation methods in the treatment of elderly intertrochanteric fracture patients complicated with osteoporosis" doi: 10.12037/yxqy.2020.01-12.

Event Description

It was reported that on literature review "comparison of the effects of three intramedullary fixation methods in the treatment of elderly intertrochanteric fracture patients complicated with osteoporosis", 2 patients suffered from a screw cut-out after having an internal fixation with the intertan system.It is unknown how the adverse event was treated.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, the literature article was reviewed.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 products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the devices to the reported events 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.

• 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: 14053567
• MDR Text Key: 288879586
• Report Number: 1020279-2022-01563
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02100106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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