MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74123152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/27/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
''us legal'': it was reported that the plaintiff underwent a primary bhr surgery in his right hip on (b)(6) 2012 due to osteoarthritis.Immediate post-operative radiograph revealed a subluxation of the femoral head anteriorly due to the patient's dense neuromuscular block secondary to regional anesthetic.A close reduction was performed in the pacu to solve this adverse event.Postoperative radiograph revealed no fractures, dislocations and appropriately positioned components.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6.It was reported that following a primary right hip surgery, the patient had a subluxation of the femoral head from transfer off the operating room bed to the hospital bed and required a closed reduction in the post-anaesthesia care unit (pacu).As of today, the implanted devices, both of which were used in treatment, have been requested for this complaint but have not become available.A review of the historical complaints data for the femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Another similar complaint was identified to involve this batch and this failure will continue to be monitored.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.A non-conformance was identified for the casting paperwork for the femoral head.However, all supporting documents confirm that this was an acceptable product when released.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The immediate post-op subluxation happened as a result of movement of the patient during a patient transfer resulting in a closed reduction.Therefore, the subluxation and subsequent closed reduction are not associated with implant failure or mal performance of the implant.Based on the information provided, we can confirm this complaint.A probable root cause of the reported failure is the movement of the patient during the patient transfer.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: FEMORAL HEAD 52MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13758778
• Report Number: 3005975929-2022-00054
• Device Sequence Number: 12218944
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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 Expiration Date: 08/01/2016
• Device Model Number: 74123152
• Device Catalogue Number: 74123152
• Device Lot Number: 11HW33910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP HAP SIZE 52/58-11(B)(6)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown