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

Catalog Number 71364011

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2019

Event Type  Injury  

Event Description

It was reported that upon insertion of the synergy stem , doctor noticed that the tip of the threads had snapped off and were fish with the stem and was decided to left it as doctor felt it posed non threat.No delay and back-up device was available.No injuries or patient impact reported.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the threaded end of the device fractured off and was not returned.The device was manufactured in 2010 and exhibits signs of extensive wear/usage.The tip fracture is most likely due to impact forces.If during impaction, sufficient side loads are transferred to the tip of the device, a mechanical overload or fatigue fracture can occur.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The clinical medical investigation concluded that, based on the reported condition of the 10 year old instrument, the ¿extensive wear/usage¿ cannot be ruled out as a possible contributing factor to the broken/retained impactor tip.The retained 17-4ph stainless steel tip is not an implantable alloy; therefore, long-term implantation data is not available but the exposure will be limited while it remains within the stem.No patient impact was reported as a result of the retained threaded tip; however, possible corrosion, micro-motion and/or migration cannot be definitively ruled out, although reportedly the surgeon ¿felt it posed no threat¿.No further medical assessment needed.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: STEM IMPACTOR ROD
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8362198
• MDR Text Key: 136880597
• Report Number: 1020279-2019-00749
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199270
• UDI-Public: 03596010199270
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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: 71364011
• Device Lot Number: 10CM06671
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR