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

Catalog Number 74123144

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 03/16/2016

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis.During the revision the bhr head was removed.The bhr cup remains 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 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.This 60 yr.Old female underwent a rt.Bhr revision approximately 7.5 years post implantation due to report of rt.Hip pain not responding to conservative measures.There is no report of any patient comorbidities or allergies, nor the treatment measures attempted.The revision report states that intraoperatively there was significant reaction to the metal with discoloration, hypertrophy and necrosis of the synovial lining.However, there is no report, or results of any cultures taken.The clinical symptoms of the reported metallosis and hip pain may be consistent with an adverse reaction to metal debris but this cannot be confirmed based on the information provided.The source of the discoloration, hypertrophy and necrotic synovial lining cannot be confirmed and it cannot be concluded that the clinical symptoms are associated with a mal-performance of the implant.It was also noted that use of a competitor's (stryker) dual mobility liner, femoral stem and femoral head devices were implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, "do not mix components from other manufacturers." 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7095152
• MDR Text Key: 94089631
• Report Number: 3005975929-2017-00445
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 08EW17044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2008
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR