• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120148
Device Problems Device Slipped (1584); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Toxicity (2333); Injury (2348)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative

As this complaint is also being handled through smith & nephew's legal teams, any responses to these queries are not immediately available to the members of smith & nephew's regulatory team and are not expected to be available for several months, if ever. This is because the timing of device return / the delivery of the information is in the control of the patient's solicitors, not smith & nephew. Smith & nephew's legal teams have confirmed that if they receive additional relevant information on this complaint (reason for complaint, including part/lot, patient, surgeon, device availability, dates of implantation or revision), they will inform us, at which point the complaint will be reopened for investigation.

 
Event Description

It was reported that right hip revision surgery was performed due to metallosis, with loosening of hardware and bone loss.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACETLR CUP HAP 48MM W/ IMPTR
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
sarah freestone
0447940038
MDR Report Key8801646
MDR Text Key151406874
Report Number3005975929-2019-00271
Device Sequence Number1
Product Code NXT
Combination Product (Y/N)N
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2012
Device Catalogue Number74120148
Device LOT Number076584
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/18/2019 Patient Sequence Number: 1
Treatment
FEMORAL HEAD, PART AND LOT # UNKNOWN
-
-