MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDCE FRCPS W/ SRRTD JW; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71173378

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that two rdce frcps w/ srrtd jw broke during an unknown procedure, instruments inside patient.S&n backup device available.Unknown if pieces of the device felt inside patient wound.

Event Description

It was reported that two rdce frcps w/ srrtd jw broke during procedure, instruments inside patient.The procedure was finished using a competitor device.No delay reported.

Manufacturer Narrative

G3, h2, h3 and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that without the requested clinical information, operative report or the device the root cause of the reported breakage cannot be determined.The retained non-implantable broken piece is comprised of din 1.4021 martensitic-ss.Therefore, the impact to the patient is the retained non-implantable broken piece.However, the potential for corrosion, local irritation/discomfort and micro-motion/or migration cannot be determined.It was reported the procedure completed with a competitor¿s device without a significant delay or patient harm.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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 repeated use can occur.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 return of the actual product involved or product information, our investigation could not proceed.Should the device 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.B5: description summary updated.

• Brand Name: RDCE FRCPS W/ SRRTD JW
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11091708
• MDR Text Key: 224243989
• Report Number: 1020279-2020-07965
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010519542
• UDI-Public: 03596010519542
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71173378
• Device Catalogue Number: 71173378
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention