MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 74122550

Device Problems Corroded (1131); Pitted (1460)

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

Event Date 05/13/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Upon removal of the head, surgeon noticed taper corrosion.

Manufacturer Narrative

A hemi head (details not visually confirmed - 74122550, 08ew17174 sn (b)(6)), modular sleeve (details not visually confirmed ¿ part and batch number obscured) were received for investigation following hip revision surgery for elevated serum cobalt and chromium and fluid with pain.Visual inspection was carried out on the returned devices.A wear patch, patches of discolouration and damage on the bearing surface of the hemi head.Surface texture changes and discolouration were also observed on the internal sleeve taper.Wear analysis was performed to review linear wear on the bearing surface of the hemi head.The wear images identified one wear patch and one area of damage on the bearing surface of the head, maximum linear wear for the hemi head was 19.5m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 141.9m.The linear wear on the bearing surface was 19.5m.Time in vivo is needed to compare the 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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the modular sleeve.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 similar complaints have been identified for the hemi head, this will continue to be monitored.The production records were reviewed for the known 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.No further actions are required at this time.No medical records have been received on this complaint.The surgeon communicated via email that the revision was performed due to elevated serum cobalt and chromium and fluid with pain, and at time of the modular exchange, the taper was noted to have minimal corrosion with black staining; alval suspected but pathology did not confirm.The devices were returned and analyzed, and found there to be wear patches on the bearing surfaces.However, without supporting medical records, radiographic images, lab/pathology results the reported event cannot be assessed and a thorough medical assessment cannot be performed.Upon receipt of medical/clinical records, the clinical task will be re-opened and assessed at that time.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If additional information becomes available in the future, this case will be re-opened.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained at aurora.All of the devices were used in treatment.

• Brand Name: HEMI HEAD 50MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8631018
• MDR Text Key: 145733964
• Report Number: 3005975929-2019-00218
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00885556071205
• UDI-Public: 00885556071205
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: 08EW17174
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2019
• Patient Sequence Number: 1
• Treatment: MODULAR SLEEVE, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention