MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 08/20/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to progressive pain, elevated chromium and cobalt levels, severe osteolysis and an mrii showing a large fluid collection about the right hip consistent with adverse tissue reaction due to metal ions.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed.During the revision, the cup and the head were removed.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 femoral head and the acetabular cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for femoral head and the acetabular cup.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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.No further actions are required at this time.The available medical documents were reviewed.Based on the information provided, the reported metallosis stained synovium, bone loss and elevated metal ion levels may be consistent with findings associated with metal debris.Without supporting radiographic images, lab/pathology results, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain 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.

Manufacturer Narrative

New information: g4, d4.

Event Description

It was reported that right hip revision surgery was performed on (b)(6) 2019 due to progressive pain, elevated chromium and cobalt levels, severe osteolysis and an mri showing a large fluid collection about the right hip consistent with adverse tissue reaction due to metal ions, and evidence of significant bone loss.The bhr prosthesis were explanted and replaced with a total hip arthroplasty construct.Although no clinical signs of infection were reported, a lab culture on an acetabular membrane specimen collected intraoperatively revealed the presence of an unidentified gram-positive rod.The patient tolerated the procedure well and was brought to the pacu in stable condition.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; 0447940038
• MDR Report Key: 9085857
• MDR Text Key: 161792263
• Report Number: 3005975929-2019-00339
• Device Sequence Number: 1
• Product Code: NXT
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 74121146
• Device Lot Number: 076219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2007
• 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
• Treatment: 74120152 ACETLR CUP HAP 52MM W/ IMPTR 74907; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male