MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/25/2016

Event Type  Injury  

Event Description

It was reported revision took place due to high cocr levels and pain.It was reported there was evidence of osteolysis, hemosiderin and black debris around the acetabular component.

Manufacturer Narrative

This complaint was reopened due to receiving operative reports.It was reported that right hip revision surgery was performed due to high cocr level and pain.During the revision the bhr cup, hemi head and modular sleeve 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.According to the provided implant report, the cup remained in-vivo and has been described as slightly vertical and slightly uncovered laterally.According to the provided revision report, the patient had progressive peri-acetabular osteolysis and rising blood metal ions.During the revision, turbid fluid, synovial tissue with hemosiderin and black debris, boney ingrowth at the cup despite the massive areas of osteolysis were observed.Based on the available information the origins of nature of the reported findings remain unclear.A relation to the reported high inclination of the cup cannot be excluded.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint however, based on the available information we propose a root cause of improper loading due to the high inclination of the cup.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 a second right hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The anthology stem 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.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.A (b)(6) 2015 office visit note reported the patient¿s chromium was up to 64 and cobalt was 213.However, those lab reports were not made available.A laboratory report (b)(6) 2015 indicated cobalt as 4.6 ppb and chromium 1.3 ppb.X-ray showed osteolysis about the birmingham acetabular cup and heterotopic ossification.The intraoperative report indicated some turbid fluid that was cultured.Black debris was noted around the acetabular component and femoral head.The reported pain, elevated cobalt, osteolysis and intaroperative findings of black debris are consistent with findings associated with metallosis.However the root cause cannot be confirmed and 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: BHR ACETLR CUP HAP 56MM W/ IMPTR
• 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: 6193135
• MDR Text Key: 62952740
• Report Number: 3005975929-2016-00073
• 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,Followup,Followup
• Report Date: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 74120156
• Device Lot Number: 67069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD#74122550, LOT#10588; MODULAR SLEEVE#74222300, LOT#9974; STEM#71356003, LOT#05BM14076; HEMI HEAD#74122550, LOT#10588; MODULAR SLEEVE#74222300, LOT#9974; STEM#71356003, LOT#05BM14076
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR