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

Model Number 74121150

Device Problem Loss of Osseointegration (2408)

Patient Problems Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 12/16/2020

Event Type  Injury  

Event Description

*us legal* bilateral patient.It was reported that, after a right bhr on (b)(6) 2007 due to osteoarthritis.Plaintiff was unable to bear weight on his right side and x-rays evidence changes in the length of his legs.Plaintiff underwent right revision surgery on (b)(6) 2020 due to femoral component loosening.The surgery was a conversion to a dual mobility replacement.The patient's current condition is unknown.

Manufacturer Narrative

Internal complaint reference: case (b)(4).

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 batch numbers were provided for investigation for the femoral head, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 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 date.No other similar complaints have been identified for the part number and the reported failure mode.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 historic 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.Although radiographic evidence of changing of leg lengths by about 8 mm was reported, no medical imaging was provided.With the limited information provided the clinical root cause of the reported femoral loosening cannot be confirmed.However, the patients ¿massive size¿ cannot be ruled out as a contributing factor of the femoral loosening.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.Based on the information provided we can confirm the reported complaint, however our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive patient weight, excessive physical activity levels, unreasonable stress on replacement system, trauma to the joint replacement.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• 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: 14429526
• MDR Text Key: 291929376
• Report Number: 3005975929-2022-00251
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 159 KG