MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121154

Device Problem Compatibility Problem (2960)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip primary surgery for a bhr resurfacing on (b)(6) 2002 at (b)(6).On (b)(6) 2019 the patient received a confirmation of his cobalt poisoning due to the implants.The patient reported that a treatment including the removal of the devices took place with a different surgeon, nevertheless no explantation dates were provided.The patient outcome is unknown.

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 femoral head 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 femoral head and for the bhr cup.In the absence of the actual devices, the production records for the available dhr were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the alleged failure mode.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It was reported that the patient underwent a left hip primary surgery for a bhr resurfacing on (b)(6) 2002.On (b)(6) 2019 the patient received a confirmation of his cobalt poisoning due to the implants.The patient reported that a treatment including the removal of the devices took place with a different surgeon.The patient outcome is unknown.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but 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, 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.

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 femoral head 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 femoral head and for the bhr cup.In the absence of the actual devices, the production records for the available dhr were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the alleged failure mode.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It was reported that the patient underwent a left hip primary surgery for a bhr resurfacing on (b)(6) 2002.On (b)(6) 2019 the patient received a confirmation of his cobalt poisoning due to the implants.The patient reported that a treatment including the removal of the devices took place with a different surgeon.The patient outcome is unknown.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but 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, and our investigation remains inconclusive.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• 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: 10383060
• MDR Text Key: 202163795
• Report Number: 3005975929-2020-00285
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: 21888
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/08/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 10/01/2020
• Supplement Dates FDA Received: 08/25/2020; 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention