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

Model Number 74120152

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994); Weakness (2145)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that left hip revision surgery is scheduled to be performed.Pain, weakness, loosening / failure of the device and metallosis reported.Bilateral patient.

Manufacturer Narrative

It was reported that left hip revision surgery was being performed on or before (b)(6)2019 due to pain, weakness, loosening / failure of the device and metallosis.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 known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.The revision has not been performed as of this date.Without supporting clinical/medical documents a thorough investigation cannot be performed.After the revision is performed; should information become available this complaint can be re-assessed.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: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull, ; UK
• MDR Report Key: 7935556
• MDR Text Key: 122788251
• Report Number: 3005975929-2018-00362
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 10EW27912
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2010
• 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: 74121146/RESURFACING FEMORAL HEAD 46MM/10HW29598
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male