MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Inflammation (1932); Complaint, Ill-Defined (2331)

Event Date 09/23/2010

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported the patient is experienced right hip iliopsoas tendonitis, on the (b)(6) 2016 notification of revision received due to cyst at different hospital from study site.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to right hip pain and other complications.During the revision the bhr head and 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.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.This is a legal complaint updated to review newly submitted information for a female that participated in a bhr clinical study (subject (b)(6)).The primary surgery was performed in (b)(6) 2010.Adverse event #1 reported ((b)(6) 2010) "right hip iliopsoas tendinitis and was treated with medication.Adverse event #5 documents ((b)(6) 2011) "occasional right hip popping" with no treatment at that time.The next adverse event #6 reports ((b)(6) 2013) "right hip pain" that was treated with medication.The newly submitted information is the revision operative report from (b)(6) 2016 which is adverse event #11 (5½ years post implantation).The report states, as the post-operative diagnosis; "periprosthetic osteolysis, pain, possible mechanical loosening".In the indications portion of the report; "the patient has had pain for quite some time.The patient had metal-on-metal hip and large cystic changes to the femoral neck." (no supporting documents provided for the cystic changes.) the intraoperative note reports; "there was osteolysis involving greater than 50% of the diameter of the neck posteriorly." additionally, her metal ion levels have been monitored pre-op and each year of her follow-up, they have been mildly elevated with no peaks.The study was terminated with the removal of the prosthesis.Based on the available information, the documentation does not support the cystic changes or the mechanical loosening of the prosthesis as the indications for the revision surgery.As stated above the metal ion levels were mildly elevated and the patient experienced pain, both of which have occurred with the metal-on-metal prosthesis.However, the large amount of "osteolysis" could have contributed to this patient's pain.No current information regarding the patient's status has been presented at this time.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 52MM 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: 5952108
• MDR Text Key: 54757303
• Report Number: 3005975929-2016-00012
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2018

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: 02/28/2014
• Device Catalogue Number: 74120152
• Device Lot Number: 098907
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/08/2017
• Supplement Dates FDA Received: 11/22/2016; 02/09/2017; 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120152/ACETLR CUP HAP52MM W/IMPTR/098907 /; FEMORAL HEAD 74121146, LOT 094007; FEMORAL HEAD 74121146, LOT 094007
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 64