MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924)

Event Date 06/05/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on right hip due to: hip replacement with adverse reaction to metal, cloudy fluid in the hip, black-stained synovium and bursal tissue throughout the hip joint, and black staining in the trunnion.

Event Description

It was reported that a coversion surgery was performed on right hip due to femoral neck fracture and device malposition.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.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.Per the 1st revision report, ¿the tip of the stem of the prosthesis actually went through the calcar right near the lesser trochanter.¿ it was also reported that care was taken throughout the surgery so as not to get a crack in the calcar, since it was paper thin because of the penetration of the stem.Details regarding the patient¿s post-operative medical history, weight-bearing status, activity level and other additional clinical relevant information have not been provided.The root cause of the reported fracture and malposition of the femoral component is likely due to the penetration of the femoral stem and the possible shift in positioning and stress to the femoral neck as a result of the reported ¿paper thin¿ calcar, however the patient¿s morbidly obese condition cannot be ruled out as a contributing factor.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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: RESURFACING FEMORAL HEAD 42MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8191127
• MDR Text Key: 131206042
• Report Number: 3005975929-2018-00548
• 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: other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 74121142
• Device Lot Number: 080879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120150/ 086200; UNKNOWN BHR DEVICE/UNKNOKN LOT; UNKNOWN BHR DEVICE/UNKNOKN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR