MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120150

Device Problem Compatibility Problem (2960)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed on (b)(6) 2019.The revision surgery was performed on the hip due to impending fracture femoral neck on resurfacing bhr prosthesis right side.The patient outcome is unknown.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event has been already reported under complaint reference (b)(4), your reference 3005975929-2019-00273, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

Same incident as mdr 3005975929-2020-00472.It was reported that right 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.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head.A similar complaint has been identified for the cup.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.A documentation error was found in the dhr review which was investigated, this had no effect on the efficacy, quality or performance of the product.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.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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: ACETLR CUP HAP 50MM 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10913544
• MDR Text Key: 218494151
• Report Number: 3005975929-2020-00473
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2008
• Device Model Number: 74120150
• Device Catalogue Number: 74120150
• Device Lot Number: 28224
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR