MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74121150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a primary right bhr surgery performed of (b)(6) 2005, the patient presented femoral neck osteolysis.This adverse event was addressed via revision surgery on (b)(6) 2022.The patient was placed in lateral position and posterior approach used to revise the bhr.Femoral neck resected and primary stem with bhr dual mobility liner implanted.No further information is available.
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part number was provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of the historical complaints data for the 74121150 resurfacing femoral head 50mm was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware/reopen date.Other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored.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.A review of historical corrective and preventive actions, preliminary risk assessment, health hazard evaluations, and field actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.It was reported, the patient developed femoral neck osteolysis and had a revision.It is noted, no medical records were available.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical/clinical records are received, the clinical task may be re-opened, and a thorough assessment will be rendered at that time.The patient impact beyond the revision is unknown.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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: RESURFACING FEMORAL HEAD 50MM
• 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: 15136791
• Report Number: 3005975929-2022-00443
• Device Sequence Number: 14801356
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

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?: No
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/30/2022
• Supplement Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown