SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
|
Back to Search Results |
|
Model Number 74123156 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Necrosis (1971); Pain (1994); Unequal Limb Length (4534)
|
Event Date 02/02/2022 |
Event Type
Injury
|
Event Description
|
Us legal.It was reported that, after a left bhr on (b)(6) 2021 due to advanced degenerative joint disease, pain, and hip impingement.The plaintiff has experienced pain and leg length discrepancy.X-rays showed femoral neck failure from avn and the prothesis collapsing into varus.Plaintiff underwent a revision surgery on (b)(6) 2022.The patient's current condition is unknown.
|
|
Manufacturer Narrative
|
Internal complaint reference: case (b)(4).
|
|
Manufacturer Narrative
|
It was reported that left hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for the femoral head for investigation, a complaint history review, manufacturing record review, device labelling / ifu review and historical review of the escalation actions 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.The available medical documents were reviewed.The reported pain, and progressive leg-length discrepancy is consistent with the report of the prosthesis collapsing into varus, which was ¿likely from avn.¿ the patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint and the probable root cause for the pain, leg length discrepancy and prosthesis collapsing into varus is from avascular necrosis and not from device.Should the devices or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.
|
|
Manufacturer Narrative
|
Additional information: d4 (catalog number and udi), g4 corrected data: d1 and g2.
|
|
Manufacturer Narrative
|
It was reported that left hip revision was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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 number and the reported/related failure mode to evaluate patterns of repeated failures or defects.Other similar complaint was identified for the part number and the reported/related failure mode.This will continue to be monitored.As no device batch numbers were 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 products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The reported pain, and progressive leg-length discrepancy is consistent with the report of the prosthesis collapsing into varus, which was ¿likely from avn.¿ the patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.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.
|
|
Search Alerts/Recalls
|
|
|