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

Model Number RESURFACING FEMORAL HEAD 42MM

Device Problems Break (1069); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Toxicity (2333); Injury (2348)

Event Date 05/20/2020

Event Type  Injury  

Event Description

It was reported that a bhr 42 femoral head was put in 2007, was removed due to neck fracture and metallosis.No further complications during the procedure have been reported.

Manufacturer Narrative

It was reported that a bhr 42 femoral head that was put in 2007, was removed due to neck fracture and metallosis.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 manufacturing record review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated 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.

• 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: 10168038
• MDR Text Key: 195602260
• Report Number: 1020279-2020-02511
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RESURFACING FEMORAL HEAD 42MM
• Device Catalogue Number: 74121142
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/20/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention