MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71364011
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a total right hip replacement (thr) surgery performed on (b)(6) 2025; a broken piece of foreign metal was discovered by the surgeons during a routine postoperative x-ray on (b)(6) 2025.The fragment, described as a metallic wire located in the soft tissue lateral to the neck of the prosthesis, was suspected to be a loose part from one (1) stem impactor rod.The finding was confirmed by a second x-ray on (b)(6) 2025.This adverse event was resolved by a subsequent surgical exploration performed later that same day, during which the metallic fragment was successfully removed from the patient.The current health status of the patient remains unknown.
Additional Manufacturer Narrative
Additional information: h3, h6, h11.H3, h6: the associated device was returned and subjected to a visual evaluation.The distal threaded end of the device exhibited signs of significant wear and damage, numerous impact marks, and its threads were deformed or stripped, with fractured off parts.Additionally, a small curled metallic fragment, consistent in appearance with the impactor¿s thread geometry, was returned with the device.This device has been in use since 2015, so its 10 years of repeated usage explain the extensive wear and tear.According to the instructions for use, "instruments which have experienced extensive use or excessive force are susceptible to fracture.Instruments should be examined for wear or damage and proper operation prior to surgery.Failure to do so may result in injury to the surgical team and/or the patient".As indicated in the instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopaedics devices, for all reusable devices it is necessary to ¿visually inspect for damage or wear, including components in their disassembled state prior to re-assembly.Ensure components are re-assembled securely¿, as well as ¿the useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device¿.The manufacturing records confirm that the device met all applicable specifications at the time of release for distribution in 2015.There is no record, in the complaints database, of similar cases associated with this product batch.While a definitive root cause for the observed device fracture could not be determined, potential contributing factors include but are not limited to extensive/prolonged use, improper handling/maintenance during reprocessing, and/or excessive force placed on the device during use.No further investigation is warranted at this time.Should additional information be received, the investigation will be reopened.

• Brand Name: STEM IMPACTOR ROD
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21931856
• Report Number: 1020279-2025-00743
• Device Sequence Number: 20995476
• Product Code: JDG
• UDI-Device Identifier: 03596010199270
• UDI-Public: 3596010199270
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71364011
• Device Lot Number: 15AM15919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown