MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PRSTHESIS, HIP, SEMICONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Device Slipped (1584); Unintended Movement (3026)

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

Event Date 02/11/2009

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening of acetabular component.Head remained in situ.There was a subsequent event for this same patient on (b)(6) 2016 already reported under (b)(4), mdr 3005975929-2018-00134.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to loosening of acetabular component.During the revision surgery bhr cup was removed.The bhr head remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.According to the provided revision report, the patient developed pain 9 days post-implantation, had a negative workup and a 2 cm lucency at the cup which was new compared to immediate post-operative, there was no evidence of bone ingrowth and a ct showed no other pathology like fractures.Review of the provided implantation and revision report did not show any findings that could explain the early loosening of the cup, respectively why the press-fit/initial fixation did not hold.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 52MM W/ IMPTR
• Type of Device: PRSTHESIS, HIP, SEMICONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7565955
• MDR Text Key: 109949205
• Report Number: 3005975929-2018-00190
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 090805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121146(B)(4).; 74121146/085804
• Patient Outcome(s): Hospitalization; Required Intervention