MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Injury (2348); Arthralgia (2355); No Known Impact Or Consequence To Patient (2692); Test Result (2695); Metal Related Pathology (4530)

Event Date 11/27/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed in (b)(6) 2015.

Manufacturer Narrative

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.- attachment: [193082 summary.Pdf].

Event Description

Revision was performed due to elevated levels of cobalt and chromium in the patient's blood.

Manufacturer Narrative

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.Without definitive part/lot numbers a complete complaint history review cannot be performed for the stem or head involved.A review of the complaint history was performed using the part numbers for the head and stem in search of complaints involving elevated test results throughout the lifetime of the product.Similar complaints have been identified for the head.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for the stem.No part/lot numbers were provided for the head and the stem; hence documentation review could not be completed.If more information is received, this investigation will be reopened.In the absence of the actual devices, the production records were reviewed for the cup and sleeve reportedly involved in this incident.The released devices met manufacturing specifications at the time of production.Review of the product ifu for those batches identified found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The complaint information has been translated and reviewed.However, no medical documents, lab reports or x-rays related to the reported left hip revision have been provided for inclusion in this investigation.Therefore, a thorough medical assessment is not able to be performed.If notification is received that additional medical documentation has been provided, this complaint will be reevaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

Left hip revision surgery was performed due to elevated metal ion levels.

• Brand Name: BHR ACETABULAR CUP 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9108643
• MDR Text Key: 161842654
• Report Number: 3005975929-2019-00354
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 74122150
• Device Lot Number: 10DW27226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 02/04/2021
• Patient Sequence Number: 1
• Treatment: 30011 GAIA MEDIAL CEMENTLESS SZ11.; 74222144 BHR MODULAR HEAD 44MM.; 74222300 MOD SLV +4MM 12/14 10DT41995.; BHR MODULAR HEAD # 74222144, LOT # 09JW24658 009.; BHR MODULAR HEAD, # 74222144, LOT # UNKNOWN.; BHR MODULAR SLEEVE, # 74222300, LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN.; THIRD PARTY FEMORAL STEM, # PART AND LOT # UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention