MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

It was reported that a patient underwent revision surgery due to pain and metallosis.The patient presented rising cocr blood levels.The dr.Converted to bhr dual mobility implant.

Manufacturer Narrative

H3, h6: a hemi head (part 74122550, lot 08mw20363) and modular sleeve (details obscured) were received for investigation following hip revision surgery performed due to pain and metallosis.All of the devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.Without definitive part/lot numbers a complaint history review, manufacturing record review and device labelling / ifu review could not be performed for the cup, sleeve and stem involved.A review of the complaint history for the hemi head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.The production records were reviewed for the known device 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 and no further actions are required at this time.Visual inspection was carried out on the returned devices.Fine scratches and discolouration were observed on the bearing surface of the head.Damage was observed on the rim of the head.The sleeve could not be separated from the head without using excessive force.Wear analysis was performed to review linear wear on the bearing surface of the hemi head.The wear images identified a wear patch on the bearing surface of the hemi head.Maximum linear wear for the hemi head was 29.5m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 150.7m.Time in vivo is needed to compare the measured linear wear for this device with the historical wear data for a non-edge loaded smith and nephew large diameter metal-on-metal device.Material loss was measured on the internal taper of the sleeve.The available medical documents were reviewed.With the limited information provided, the clinical root cause of the ¿rising cobalt and chromium levels¿, reported pain and metallosis cannot be confirmed, and it cannot be concluded that the reported reactions were 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.No further clinical assessment is warranted at this time.Based on the analysis of the returned parts and the information provided the root cause remains undetermined after investigation.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained at smith+nephew and are available upon request.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11043005
• MDR Text Key: 222629370
• Report Number: 3005975929-2020-00516
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 168