Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 54MM
  • 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 BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 54MM Back to Search Results
Catalog Number 74122154
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)
Event Date 09/28/2018
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was scheduled to be performed.Pain, popping of the hip joint, difficult mobility, and elevated metal ion levels reported.
 
Manufacturer Narrative
As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.Concomitant medical products : 74122548/hemi head 48mm/unknown remain the same the other two changed for 71357008/anthology so porpl hasz 8/unknown and 74222100/modular sleeve -4mm 12/14/unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIRMINGHAM HIP RESURFACING
Type of Device
BHR ACETABULAR CUP 54MM
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, warwickshire CV31 3HL
UK  CV31 3HL
MDR Report Key7977124
MDR Text Key124066801
Report Number3005975929-2018-00385
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010552297
UDI-Public03596010552297
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74122154
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
71357008/ANTHOLOGY SO PORPL HASZ 8/UNKNOWN; 74222100/MODULAR SLEEVE -4MM 12/14/UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
-
-