MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD TRIAL 12/14 40 +0; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CNSTRAIND,CMNTD,MTL/POLYMER

Model Number 71366517

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that after trialing the +0 head.It was noticed the prongs had snapped off.They were removed from patient.Patient was not harmed.It occurred during use of the instrument.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports the femoral head trial prongs snapped off during use.Per complaint detail, the prongs were removed and there was no harm to the patient.It is unknown if there was a surgical delay, or if a backup device was used.Therefore, since no patient harm is alleged, no further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.We consider this investigation closed.

• Brand Name: FEMORAL HEAD TRIAL 12/14 40 +0
• Type of Device: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CNSTRAIND,CMNTD,MTL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558418
• MDR Text Key: 207687028
• Report Number: 1020279-2020-04738
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556110119
• UDI-Public: 00885556110119
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71366517
• Device Catalogue Number: 71366517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention