MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 40MM; PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

Model Number 71332540

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 10/25/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed for the third time.Aseptic loosening.Hip prepped and draped, jointly opened, specimens taken.Joint lavaged and debrided intensely.The femoral head removed, poly liner and cup and screws removed.Existing socket reamed to a bleeding bone bed.Implant trialed, joint lavaged again with hydrogen peroxide and more saline.Definitive acetabular implant inserted with bone cement.Tripolar liner/head trialed via reduction, hip stable, definitive tripolar implants inserted and hip reduced, hip closed.No more information is available.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it was reported that a revision surgery was performed for the third time this year (2019) due to aseptic loosening.No supporting medical documentation was provided; therefore a thorough medical investigation could not be performed.Aseptic loosening was reportedly the cause.The patient impact beyond the loosening and revision procedure could not be determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include a fit/ sizing issue, poor ingrowth or osteolysis.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF SPHER HEAD SCREW 40MM
• Type of Device: PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9353653
• MDR Text Key: 167340359
• Report Number: 1020279-2019-04114
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010463296
• UDI-Public: 03596010463296
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71332540
• Device Catalogue Number: 71332540
• Device Lot Number: UNKNOWN/UNREADABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1