MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74123144
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up¿ 2.2 years after a bhr surgery, one (1) patient developed subsidence of the femoral component due to femoral head collapse and pain.Revision surgery was performed to explant both implants.The patient outcome and current health status is unknown.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).Article cite: samuel, l.T., zuke, w.A., mahmood, s., munim, m.A., alamir, p.B., & brooks, p.J.(2022).Hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up.The journal of arthroplasty, s0883-5403(22)00399-0.Advance online publication.Https://doi.Org/10.1016/j.Arth.2022.04.008.
Additional Manufacturer Narrative
It was reported in a literature review that a bhr revision surgery was performed due to femoral head subsidence, collapse and pain.As of today, the implanted devices, all of which were used in treatment are not accessible for testing.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the femoral head.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the femoral head.However, as the device is no longer sold, no action is to be taken.As no device batch 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 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 historic escalation actions related to the product and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.However, we cannot rule out the reported femoral head collapse, as a likely contributory factor.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.Should the device 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 44MM
• 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: 14431325
• Report Number: 3005975929-2022-00260
• Device Sequence Number: 20205743
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 03596010552419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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 Model Number: 74123144
• Device Catalogue Number: 74123144
• Device Lot Number: UNKNOWN
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 09/13/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/14/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL HEAD 44MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female