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

Catalog Number 74122158

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 02/01/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain and clunking of bearing.Large lytic lesion found to continue in proximal femoral metaphasis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due pain and clunking of bearing.At the time of revision, both the bhr head & 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 devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.The supplied medical documents were reviewed.Based on the provided information there was a large amount of grey material inside the femoral, large lytic lesion in the femur and pelvis leading to significant structural defects.No actual revision report was provided.The provided x-rays dated 2 days before the revision show that edge-loading occurs to the extent that the femoral component is nearly located outside the cup.The cup position is very steep, which might be a result of cup migration.However, without x-rays dated after implantation, this cannot be verified.The femoral bone is possibly articulating with the cup.The provided image of the acetabular shell shows a large defect at the rim including a thinned wall of the rim.This could match the position of the femoral component seen on the x-rays.Without the devices this cannot be verified.The pain and clunking can be explained by the findings from the x-rays.Although the devices involved in this incident were not returned for analysis, images of the explants were provided.Visually analysis of the photo of the bhr cup confirmed that exceptionally high amounts of edge wear have taken place on this device, as evidenced by the device wearing through the rim of the cup and down to the porocast layer below the bhr cup rim.This wear is consistent with the x-ray position of the bhr head positioned partially outside the bhr cup in an edge loading orientation.Images of the bhr head were not clear enough to discern if corresponding damage to the bhr head had occurred.The excessive wear observed on the bhr cup photograph exceeds that of any bhr cup retrieval received by smith & nephew to date.Without the actual devices, the actual amount of wear of the implant cannot be quantified.The available information suggests the root cause of the reported clunking and pain was device orientation and articulation which led excessive wear due to improper loading (edge loading) of the implants.The returned devices would be required to quantify the extent of wear present.It is unclear if the devices were originally inserted in this orientation, or if device migration occurred over time leading to the device positions noted before revision.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: BHR ACETABULAR CUP 58MM
• 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: 7248439
• MDR Text Key: 99241744
• Report Number: 3005975929-2018-00041
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 74122158
• Device Lot Number: 10764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123152 LOT NUMBER 07JW14025; FEMORAL HEAD, # 74123152, LOT # 07JW14025; FEMORAL HEAD, # 74123152, LOT # 07JW14025
• Patient Outcome(s): Hospitalization; Required Intervention