• 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 60MM W/ IMPTR; BHR ACETABULAR CUP

  • 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 60MM W/ IMPTR; BHR ACETABULAR CUP Back to Search Results
Catalog Number 74120160
Device Problems Degraded (1153); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Synovitis (2094); Toxicity (2333); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)
Event Date 03/23/2018
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to persistent unrelenting left hip pain secondary to metallosis, difficulty walking, and adverse local tissue reaction consistent with elevated chromium and cobalt levels, from failed right hip resurfacing arthroplasty consistent with metal-on-metal wear.Operative findings consistent with metallosis, including stained tissue, and metal-induced synovitis were reported.
 
Manufacturer Narrative
It was reported that left hip revision surgery was performed due to persistent unrelenting left hip pain secondary to metallosis, difficulty walking, and adverse local tissue reaction consistent with elevated chromium and cobalt levels, from failed right hip resurfacing arthroplasty consistent with metal-on-metal wear.During revision, the bhr cup and the bhr head were removed.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.Revision had findings consistent with metallosis, including stained tissue, and metal-induced synovitis.Although elevated cobalt and chromium levels were reported neither pathology or laboratory reports were provided for review.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported pain, elevated cobalt and chromium levels, stained synovial tissue, and synovitis found intraoperatively cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.
 
Manufacturer Narrative
It was reported that the left hip revision surgery was performed.During the revision, the cup and head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the acetabular cup and the femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the acetabular cup and the femoral head.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.The reported findings aseptic lymphocytedominant vasculitis-associated lesion (alval), stained tissue and metallosis may be consistent with findings associated with metal debris.The patient¿s reported falls may have been a contributing factor to the presence of metal-induced synovitis but as they occurred after the mri reporting alval changes the noted falls are not likely the root cause.Although elevated cobalt and chromium levels were reported, neither pathology nor laboratory reports were provided for review.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported pain, elevated cobalt and chromium levels, stained synovial tissue, and synovitis found intraoperatively cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACETLR CUP HAP 60MM W/ IMPTR
Type of Device
BHR ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, warwickshire CV31 3HL
UK  CV31 3HL
MDR Report Key7836335
MDR Text Key118867470
Report Number3005975929-2018-00291
Device Sequence Number1
Product Code NXT
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,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2012
Device Catalogue Number74120160
Device Lot Number081490
Was Device Available for Evaluation? No
Date Manufacturer Received06/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL HEAD 54MM 74121154 LOT 082007; FEMORAL HEAD, PART AND LOT NUMBER UNKNOWN; FEMORAL HEAD, PART AND LOT NUMBER UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
-
-