SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74121150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
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Event Date 10/22/2019 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed on the patient right hip due to experiencing pain and limping on the right side.It was discovered he experienced elevated cobalt and chromium levels in (b)(6) 2019.The patient outcome is unknown.
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Manufacturer Narrative
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It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.Due to lack of device details provided, a documentation review could not be performed for the devices reportedly involved in this incident.If further information is received, the documentation review will be reopened and completed.The available medical documents were reviewed.Although elevated metal ions were reported, neither the lab values or laboratory reports were provided.Without status post implantation and pre-revision x-rays and/or the analysis of the explanted components; the root cause of the reported pain, limping and femoral component loosening cannot be confirmed and it cannot be concluded that the reported events were associated with a mal-performance of the implant; however, the reported pain and limping may be consistent with symptoms associated with the loosened femoral component.The patient¿s history of morbid obesity with a bmi>50 and avascular necrosis cannot be ruled out as contributing factors to his pain and clinical status.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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Event Description
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It was reported that, after undergoing right hip resurfacing (bhr) on (b)(6) 2011 due to advanced hip arthrosis, the patient experienced femoral component loosening along with pain and limping.This complication was treated by performing a revision surgery on (b)(6) 2019, in which the resurfacing head was removed, and the acetabular cup was retained.During this procedure, clear joint fluid was found and cultured.Conversion to tha was conducted by placing a smith and nephew sl-plus stem and oxonium femoral head, along with a competitor¿s acetabular a dual mobility liner (biomet).The patient was taken to the recovery room in stable condition.
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Manufacturer Narrative
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H3, h6: it was reported that a right hip revision surgery was performed due to femoral component loosening, pain and limping.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the cup and the head, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.Without the status post implantation and the pre-revision x-rays and/or the analysis of the explanted components; the root cause of the reported pain, limping and femoral component loosening cannot be confirmed and it cannot be concluded that the reported events were associated with a mal-performance of the implant; however, the reported pain and limping may be consistent with symptoms associated with the loosened femoral component.The patient¿s history of morbid obesity with a bmi>50 and avascular necrosis cannot be ruled out as contributing factors to his pain and clinical status.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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 and 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.
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