MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71365705

Device Problem Device Fell (4014)

Patient Problem Injury (2348)

Event Date 01/31/2019

Event Type  Injury  

Event Description

It was reported that during surgery the screw holding the stem on the handle broke in the implant, could not be removed so it stayed in the stem inside the patient.No delay was reported and no backup device was available.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

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, rendering the device inoperable.The tip was not returned.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.The fracture is most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts occurring while the inserter is not fully captured in the driver hole platform of the stem.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 medical investigation concluded that, based on the limited information provided, the root cause of the reported broken threaded tip cannot be determined.The 17-4ph is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.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.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8370257
• MDR Text Key: 137144075
• Report Number: 1020279-2019-00801
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71365705
• Device Lot Number: 13MM00893
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention