MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74121138
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received a birmingham hip resurfacing and now needs the femoral component revised due to fracture due to a fall in (b)(6) 2018.A custom dual mobility insert is planned to treat the patient.Therefore at present, no revision operation has occurred but will be performed.
Additional Manufacturer Narrative
It was reported that a custom-made device was requested for a planned hip revision surgery.The implanted devices were all used in treatment.As of today, additional information has 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 bhr dysplasia cup and stem involved.A review of the complaint history for the modular head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the known 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.No additional risks were identified as result of the reported event and no further actions are required at this time.Several attempts have been made to acquire clinical/medical records to not avail.No indications have come in that give the status of the reduction of the fracture, or the revision of the hip.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without 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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 38MM
• Common Device Name: 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: 8499207
• Report Number: 3005975929-2019-00163
• Device Sequence Number: 14082340
• Product Code: NXT
• UDI-Device Identifier: 03596010502766
• UDI-Public: 03596010502766
• 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: 2003
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: 74121138
• Device Catalogue Number: 74121138
• Device Lot Number: 8880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74120246 DYSPL CUP HAP 46MM W/ IMPTR; UNKN01102100 UNKN BHR IMPLANT; UNKNOWN BHR DEVICE; UNKNOWN BHR DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR