MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

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

Patient Problem Hematoma (1884)

Event Date 02/26/2020

Event Type  Injury  

Event Description

It was reported that, after a revision surgery for a bhr implant, the patient presented a hematoma.A revision surgery with aspiration was performed to address this adverse event; during this procedure no implants were removed.The patient outcome is unknown.

Manufacturer Narrative

It was reported that the patient underwent a revision surgery.During this procedure no implants were removed.The implanted devices, were all used in treatment.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup.However, as the device is no longer sold, no action is to be taken.Without definitive part/lot numbers for the head a complete complaint history review cannot be performed for this device.In the absence of the actual devices, 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.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels and the necrotic tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The hematoma post revision was likely due to his factor 5 leiden mutation.Based on the information provided a probable root cause of the hematoma is the patient¿s pre-existing condition of factor 5 leiden mutation.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.

• Brand Name: ACETLR CUP HAP 52MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10852877
• MDR Text Key: 216644023
• Report Number: 3005975929-2020-00446
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 3596010502575
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120152
• Device Lot Number: 13BW09400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP FEMORAL HEAD; UNKN BIRMINGHAM HIP FEMORAL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention