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

Model Number 74123144

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 01/01/2016

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 291965796
• Report Number: 3005975929-2022-00260
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 03596010552419
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 07/12/2022; 09/13/2022
• Supplement Dates FDA Received: 07/14/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 44MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female