MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/19/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to the patient due to an infection.Three devices explanted.No additional information available.

Manufacturer Narrative

It was reported that a revision surgery was performed to the patient due to an infection.The associated acetabular cup, tandem unipolar and cobalt chrome high offset stem were not returned for evaluation.Therefore, no product analysis could be performed.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, a device history record and sterilization documentation review cannot be completed.Also, a complaint history review could not be performed with any accuracy due to lack of batch information.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved and no lab results, our investigation of this report is inconclusive.It should be noted that a bhr cup being used with a tandem unipolar head is considered off label per our product development engineer.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: ACETLR CUP HAP 58MM 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 TN CV31 3HL; UK CV31 3HL
• MDR Report Key: 8601010
• MDR Text Key: 144738879
• Report Number: 1020279-2019-01872
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120158
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention