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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74120150
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Toxicity (2333)
Event Date 03/16/2020
Event Type  Injury  
Event Description
It was reported a revision surgery due to complications with metal toxicity.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the current event has been already reported under reference 3005975929-2020-00056, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
ACETLR CUP HAP 50MM 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 CV31 3HL
UK  CV31 3HL
MDR Report Key9955493
MDR Text Key187506614
Report Number3005975929-2020-00105
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010502568
UDI-Public03596010502568
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/29/2013
Device Model Number74120150
Device Catalogue Number74120150
Device Lot Number089744
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL HEAD 74121142/ 083402.
Patient Outcome(s) Required Intervention;
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