MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRAUMA & EXTREMITIES DEV; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problems Failure of Implant (1924); Deformity/ Disfigurement (2360)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that on literature review "removal of antibiotic cement-coated interlocking nails", 4 patients suffered from implant prominence and were indicated for removal or exchange of the interlocking nailing system.The primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent (off-label use of the implant).The current state of health of the patients is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it should be noted, the primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent is an off-label use of the implant.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would 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.Possible causes could include but not limited to traumatic injury, surgical technique, size of device, abnormal loading of limb, user/procedural variance and off-label use.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 product 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 TRAUMA & EXTREMITIES DEV
• 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: 15242667
• MDR Text Key: 298071767
• Report Number: 1020279-2022-03700
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other