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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2020-01953
• Device Sequence Number: 14283082
• Product Code: LZO
• UDI-Device Identifier: 03596010196187
• UDI-Public: 3596010196187
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K971414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71320028
• Device Lot Number: T04950001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention