MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)

Event Date 07/01/2013

Event Type  Injury  

Event Description

It was reported that a bhr revision was performed due to deep infection, pain, aval and pseudotumor.

Manufacturer Narrative

It was reported that a hip revision surgery was performed.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the cup.A review of the complaint history for the modular head, modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the modular head, modular sleeve and stem, this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the 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.It was also confirmed that all devices were sterilised.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.No further actions are required at this time.The available medical documents were reviewed.This is an anthology study.It was reported that a bhr revision was performed due to deep infection, pain, aval and pseudotumor.To date no medical/clinical documentation has been provided.Without the requested patient specific clinical information a thorough medical investigation cannot be rendered.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 54MM
• 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: 9732496
• MDR Text Key: 180747556
• Report Number: 3005975929-2020-00071
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74222154
• Device Lot Number: 10742
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120160 ACETLR CUP HAP 60MM W/ IMPTR; ANTHOLOGY 71357010/ 6AM12601A; MODULAR SLEEVE 74222200/ 9971
• Patient Outcome(s): Hospitalization; Required Intervention