MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122546

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

Patient Problem Insufficient Information (4580)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a bhr resurfacing procedure, patient was entered to have revision surgery.It is unknown what was the adverse event the patient experienced.This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange an unknown birmingham hip resurfacing (bhr) head.Patient's current health status is unknown.

Event Description

It was reported that, after a bhr resurfacing procedure, patient was entered to have revision surgery.It is unknown what was the adverse event the patient experienced.This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange the hemi head 46mm.Patient's current health status is unknown.

Manufacturer Narrative

A 46mm hemi head (part 74122546, batch unknown) and modular sleeve (part and batch unknown) were received for investigation following hip revision surgery for an unknown reason.The devices were used in treatment.As no batch numbers were available for the devices a full complaint history review of the hemi head and sleeve could not be performed.No part number was available for the sleeve.A review of the historical complaints data for the 46mm hemi head was performed using the part number and the reported failure mode to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints were identified.As no batch numbers were available the production records for the devices could not be reviewed.Should the batch/serial number become available later then the dhr task will be reopened and completed.Insufficient information was available to determine the revision of ifu applicable to the device at the time of manufacturing.However, a review of the most recent ifu historical revision related to the devices was conducted.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.A review of historic quality escalations related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.Visual inspection was carried out on the returned devices.Fine scratches and patches of discolouration were observed on the bearing surface of the hemi head.Surface texture change and discolouration were 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 a wear patch on the bearing surface for the hemi head.Maximum linear wear for the hemi head was 10.2 m and the volumetric wear was 2.7mm³.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 179.2 m.The sleeve and head could not be separated without using excessive force.A medical investigation was performed.The provided photos and retrieval analysis report were reviewed.It is noted, the bearing surface of the head had fine scratches and patches of discoloration.Material loss, surface texture change and discoloration were noted on the internal sleeve taper.However, without additional supporting clinical documentation, the clinical events and/or patient clinical status prior to the revision is unknown.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision cannot be determined with the limited information provided.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.Based on the provided information and product evaluation a definitive root cause of the reported adverse event cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.This device will be retained.B5: event description.D1, d2, d4, d10: device information.G4: 510k.

• Brand Name: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15341547
• MDR Text Key: 299138122
• Report Number: 3005975929-2022-00465
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: UKNONWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKOWN BIRMINGHAM HIP MODULAR HEAD SLEEVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male