MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MODULAR HEAD 46 MM -8MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74121246

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

Patient Problem Metal Related Pathology (4530)

Event Date 07/05/2021

Event Type  Injury  

Event Description

It was reported that, after a left bhr-tha surgery performed on (b)(6) 2005, the patient experienced high metal ion levels.This adverse event was solved by conducting a revision surgery on (b)(6) 2021.The old 46-8 mm mmt monoblock bhr femoral head was removed with a punch and a 46 mm bhr dm insert with 28 mm plus 0 oxonium femoral head were inserted and impacted to retained femoral stem.The wound closed in layers as per standard approach.Patient current health status is unknown.

Manufacturer Narrative

G3, h2, h3, and h6: a revision surgery was performed on the left hip of the patient.As of today, the implanted devices all of which were used in the treatment, and additional information have been requested for this complaint but have not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history was performed using the part number for the modular head 46 mm, acetabular cup 48/54 mm and the stem in search of complaints involving elevated ions/ biocompatibility issues (a010101) throughout the lifetime of the product.Similar complaints have been identified for the cup and stem, this will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The parts involved would have met manufacturing specifications.If more information is received, this investigation will be reopened.No medical documentation was available for review.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: MODULAR HEAD 46 MM -8MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12160595
• MDR Text Key: 261301756
• Report Number: 3005975929-2021-00356
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 03596010503077
• UDI-Public: 03596010503077
• Combination Product (y/n): N
• PMA/PMN Number: K061243
• 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: 11/01/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121246
• Device Catalogue Number: 74121246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP/UNK; UNKN SPECTRON EF STEM/UNK
• Patient Outcome(s): Hospitalization; Required Intervention