MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problems Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 10/21/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to progressive pain, an inability to walk and elevated cobalt and chromium levels from failed right hip resurfacing arthroplasty consistent with metal-on-metal wear.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to progressive pain, an inability to walk and elevated cobalt and chromium levels.During the revision the bhr head and the bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.This legal case re-opened due to the receipt of medical documents i.E.Chart sticks, primary and revision operative reports.It was reported approximately six years post implantation of a rbhr, this 52- year old female underwent a revision due to progressive pain, an inability to walk and elevated cobalt and chromium levels from failedright hip resurfacing arthroplasty consistent with metal-on-metal wear.According to the revision report, the acetabular component was stable.However, the femoral component was loose and thefemoral neck had a subcapital fracture.These components were removed.Some of the hypertrophic fluid was sent for cultures, according to the surgeon, "no gross evidence of pathology was seen." based on the limited clinical information provided we cannot confirm the report of revision due to metal on metal wear.Neither the pathology report, explant, nor the metal ion levels were provided.Therefore it cannot be concluded whether the reported clinical reactions are associated the implant.Additionally, the root cause of the femoral component loosing and the femoral neck's subcapital fracture cannot be concluded.Although, the patient's history of avn cannot be ruled out as a contributing factor.The future impact to the patient beyond the revision cannot be concluded.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.

Manufacturer Narrative

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.A review of the complaint history for the bhr cup, bhr head, was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head and cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.It should be noted the implantation report indicated ¿most of the avascular segment was removed.¿ bhr surgical technique listed contraindications include any patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.The root cause of the reported pain, elevated ions and osteolysis cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.However, the patient¿s history of avn cannot be ruled out as a contributing factor to the varus migration of the femoral head, osteolysis and femoral neck fracture.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.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7159738
• MDR Text Key: 96223753
• Report Number: 3005975929-2018-00006
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 74122158
• Device Lot Number: 08KW19725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123152/FEMORAL HEAD 52MM/08GW17761.; FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR