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

Catalog Number 74121150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Date 08/26/2019

Event Type  Injury  

Event Description

It was reported that a left hip revision surgery was performed due to pain, metallosis, pseudotumor, inflammatory response due to metallosis, and brownish-gray metallosis type staining of local tissue.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head or cup.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 review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The reported pain, fluid around the hip and intraoperative findings of brownish-gray staining of the synovial tissue and tendon rupture may be findings consistent with metallosis.However, the root cause of the reported reactions cannot be confirmed nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond the pain, revision and expected transient post-op convalescence period cannot be determined.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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: RESURFACING FEMORAL 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: 9683556
• MDR Text Key: 178323965
• Report Number: 3005975929-2020-00048
• 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
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 74121150
• Device Lot Number: 079924
• Date Manufacturer Received: 08/18/2020
• Patient Sequence Number: 1
• Treatment: 74120158 ACETLR CUP HAP 58MM W/ IM 089140
• Patient Outcome(s): Hospitalization; Required Intervention