MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number 71365721

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 07/16/2019

Event Type  Injury  

Event Description

It was reported that the patient later suffered a periprosthetic fracture.Upon current x-rays, a foreign body was discovered at the proximal point of the stem.While performing the surgery to correct the fracture, the foreign body was determined to be the "nipple" end of the offset impactor used during the case on (b)(6).It was retrieved and removed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no clinical information was provided for inclusion in this medical investigation.Per communications, the retained foreign body was the nipple tip of the offset impactor and was removed.Should any additional information be provided, this complaint will be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ANTHOLOGY INSERTER ANT SOFT
• Type of Device: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9135165
• MDR Text Key: 160558043
• Report Number: 1020279-2019-03505
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010553409
• UDI-Public: 03596010553409
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

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 Model Number: 71365721
• Device Catalogue Number: 71365721
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR