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

Catalog Number 74121142

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 09/02/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to failed hip arthroplasty and metallosis.Bilateral patient, with right side devices still implanted.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to failed hip arthroplasty and 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 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 (b)(6) female underwent a left bhr revision ~ 8 years post implantation due to reported pain which did not respond to conservative measures.The surgical revision report states that intraoperatively, there was a significant reaction to the metal with discoloration, hypertrophy and necrosis of the synovial lining.Neither supporting intra-op findings/images nor pathology/lab results were provided.The clinical symptoms of the reported pain and discoloration, hypertrophy and necrosis of the synovial lining may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.The source of the reported symptoms cannot be determined.It was 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: 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 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 5001 ; SZ 5001
• MDR Report Key: 7059370
• MDR Text Key: 92935331
• Report Number: 3005975929-2017-00411
• 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,Followup
• Report Date: 08/13/2018

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: 10/31/2012
• Device Catalogue Number: 74121142
• Device Lot Number: 080566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 11/14/2017
• Supplement Dates FDA Received: 01/18/2018; 08/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2007
• 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: 42 YR