MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,PRS

Model Number 71336452

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that during tha surgery, the liner can't be placed smoothly after the surgeon implanted the reflection acetabular system.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes.No harm or injury reported on patient.

Manufacturer Narrative

H3, h6: it was reported that during tha surgery, the liner can't be placed smoothly after the surgeon implanted the reflection acetabular system.The affected complaint device, intended for use in treatment, was not returned and evaluated.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Since it was reported that the procedure was successfully completed using a backup device without patient injury, no further clinical/medical assessment is warranted at this time.Some potential causes could include but are not limited to limited to surgical technique or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 52MM
• Type of Device: PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,PRS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10730402
• MDR Text Key: 212863482
• Report Number: 1020279-2020-05711
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• Combination Product (y/n): N
• PMA/PMN Number: K960094
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71336452
• Device Catalogue Number: 71336452
• Device Lot Number: 19KM19600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention