MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123144

Device Problems Failure To Adhere Or Bond (1031); Unintended Movement (3026)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/21/2016

Event Type  Injury  

Event Description

It was reported the removal of a 44mm bhr head and 50mm bhr cup took place.Bhr was implanted in 2009.Head appears to be loose.Black/ grey soft tissue and bone around head and cup was noted and removed.Head was impacted off with a bone tamp.Cup removed with explant system.Revised to r3 multi hole and synergy stem.

Manufacturer Narrative

It was reported that revision was permormed due to loosening and metallosis.The bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.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 due to loosening.During surgery, the bhr cup and the bhr head 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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.This legal complaint was re-opened due to the receipt of medical operative reports and chart sticks.This case reports seven years post implantation of a rbhr, this fifty-three year old male underwent a conversion of a right birmingham hip resurfacing to right total hip arthroplasty due to loosening, metallosis, and recent radiographs that demonstrated evidence of a medial neck bony erosion at the level of the implant and progressive bone interface.Intra-operative findings: there was reported significant debris present consistent with metallosis around the periphery at the base near the neck of the femoral implant.Once the hip was then dislocated, the birmingham femoral head resurfacing was removed with several cleansing blows with a tamp and removed in its entirety.The surgeon made the femoral neck cuts approximately 1 cm below the level of the lesser trochanter allowing the surgeon to remove all of the metallosis debris.According to the report the surgeon decided to remove the acetabular component using an innomed cup remover system and noted it removed without difficulty.There was significant anteromedial bony cyst present beneath the cup that was debrided with removal of additional debris in the region with a pulse lavage.An actual size 54 multihole r3 cup was then selected.It was placed after placement of bone graft within the cystic changes noted medially with placement of several milliliters of cancellous bone.Three of the multihole screw hole positions were utilized with placement derotational screws noting good placement as well as fixation.A 20-degree posterior lip highly crosslinked polyethylene insert was used to accommodate a 36-mm head and it was noted to be appropriate for a 54-mm cup.It was placed with impaction and noted to be stable.The x-ray report, intra-operative findings, along with the clinical symptoms may be consistent with an adverse reaction to metal debris; however, without the supporting lab/pathology results, the analysis of the explanted components, the source cannot be confirmed.In addition, the head loosening was not confirmed in the operative report.We are unable to concluded whether the reported clinical reactions were associated with a mal-performance of the smith and nephew implant.The patient impact beyond the right hip revision/conversion to a rtha 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: FEMORAL HEAD 44MM
• 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: 5982916
• MDR Text Key: 55797818
• Report Number: 3005975929-2016-00017
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74123144
• Device Lot Number: 08EW17046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74122150/ACETABULAR CUP HAP SIZE 44/50/UNKNOWN /; ACETABULAR CUP #74122150, LOT UNKNOWN; ACETABULAR CUP 74122150 LOT 08JW18863; ACETABULAR CUP #74122150,
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR