MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT'L BIOLOX FORTE CER 36 HD 12/14 +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEM OR UNCEM

Catalog Number 71331048

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Information (3190)

Event Date 07/05/2012

Event Type  Injury  

Event Description

It was reported that, after a thr had been performed, the patient experienced an unidentified adverse event.A revisions surgery was performed to exchange the biolox forte 12/14 femoral head.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery of thr was performed.The biolox forte 12/14 femoral head was revised.The reason for the revision surgery is unknown.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Based on this investigation, the need for corrective action is not indicated.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 could not be performed with accuracy as the reason for the revision surgery is unknown.No medical documents were received for investigation as the information will be provided by our legal department.Without the reason for revision surgery or patient medical records available, the potential root cause cannot be determined at this time.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: INT'L BIOLOX FORTE CER 36 HD 12/14 +4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEM OR UNCEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10394405
• MDR Text Key: 202500506
• Report Number: 1020279-2020-03859
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010583239
• UDI-Public: 3596010583239
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 71331048
• Device Lot Number: 08AT16309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR