MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Implanted late 2009 / early 2010.Patient underwent a previous revision of femoral stem component only (not s&n) (b)(6) 2012.Additionally during 2012 locking screws were removed, details unknown.In (b)(6) 2014 it was decided to perform a revision surgery on the patient's right hip.Subsequent bursectomy (b)(6) 2014 and re-revision (b)(6) 2015 (sides unknown).

Manufacturer Narrative

Through a legal claim, it was reported that right hip revision surgery of a bilateral bhmh patient was performed, reporting revision of the bhmh head and modular sleeve.No details have been provided about the acetabular cup or femoral stem involved at the time of this revision.The patient reportedly was implanted late 2009 / early 2010 and underwent a previous revision of femoral stem component only (not smith & nephew) (b)(6) 2012.Additionally, during 2012 locking screws were removed, details unknown.In (b)(6) 2014 it was decided to perform a revision surgery on the patient's right hip.Subsequent bursectomy (b)(6) 2014 and re-revision (b)(6) 2015 (sides unknown).As of today, device return and additional information has been requested for this revision 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 and did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Since no underlying medical documents were received for investigation, no thorough medical investigation and assessment of the reported complaint can be performed.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 MODULAR HEAD 50MM
• 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: 7024451
• MDR Text Key: 91802944
• Report Number: 3005975929-2017-00397
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 74222150
• Device Lot Number: 08CW16198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2017
• Patient Sequence Number: 1
• Treatment: 74222200/MODULAR SLEEVE {} PLUS 0MM (B)(6) 2010 LT0145; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention