MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZIRC 12/14 FEM HD 28 + 0; PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD

Catalog Number 71320028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that, after a left-sided thr had been performed, the patient started experiencing pain.An x-ray image showed that the liner was worn, so the surgeon recommended exchanging the liner and the femoral head.A revision surgery was performed to address the issue: both components were explanted.The patient outcome is unknown.

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 the information and x-rays submitted did not provide any insight to the cause of this patient¿s pain or the wear of the polyethylene insert.This patient¿s level of activity and the age of the insert may have contributed to the issue.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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: ZIRC 12/14 FEM HD 28 + 0
• Type of Device: PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10112952
• MDR Text Key: 193614996
• Report Number: 1020279-2020-01953
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010196187
• UDI-Public: 3596010196187
• Combination Product (y/n): N
• PMA/PMN Number: K971414
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71320028
• Device Lot Number: T04950001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention