MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PORS,CLICUM-PHSPHTE

Catalog Number 71332530

Device Problems Calibration Problem (2890); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 01/02/2019

Event Type  malfunction  

Event Description

It was reported that after a total hip replacement procedure, post operative film showed that the screw had gone completely through the shell.No delay reported.No revision surgery performed.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and based on the information provided the root cause of the acetabular screw penetration cannot be definitively determined, the device remains implanted.The patient impact cannot be completed as it is unknown if migration could occur or migration of the shell at this time.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

Manufacturer Narrative

Information was received that changed the type of incident to a malfunction.Post op film showed that the screw had gone completely through the shell with no direct impact to the patient.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PORS,CLICUM-PHSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8278440
• MDR Text Key: 134116212
• Report Number: 1020279-2019-00287
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (y/n): N
• PMA/PMN Number: K990666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71332530
• Device Lot Number: 18FM08799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention