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

Model Number	74121154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2006
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr surgery performed on an unknown date, the patient experienced implant failure and unknown symptoms.To treat this adverse event, a revision surgery is needed and will be scheduled to explant a resurfacing femoral head 54mm.The explanted device will be replaced with a bhr dual mobility implant.Current patient health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a bhr surgery performed on an unknown date, the patient experienced implant failure and unknown symptoms.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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review & risk management review could not be performed.All of the devices would have met manufacturing specifications.If more information is received, this investigation will be reopened.Smith and nephew has not received 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 the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
It was reported that, after a bhr surgery performed on an unknown date, the patient experienced implant failure and unknown symptoms.As of today, the implanted devices, all of which were used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has 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 femoral head 54mm in search of complaints involving implant failure throughout the lifetime of the product.A similar complaint has been identified and this will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review/ risk management could not be performed.The parts involved would have met manufacturing specifications.If more information is received, this investigation will be reopened.A clinical investigation could not be performed as smith and nephew has not received 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 further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause linking the reported event to the device 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: RESURFACING FEMORAL HEAD 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11891192
• Report Number: 3005975929-2021-00281
• Device Sequence Number: 19179809
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 10/28/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/09/2021; 10/30/2021
• 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