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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Toxicity (2333); Arthralgia (2355)
Event Date 10/28/2016
Event Type  Injury  
Event Description
It was reported that right hip revision surgery was performed due to hip pain and other complications.In his operative note, dr.Prevost describes serum cobalt and chrome toxicity; adverse local tissue response around the right hip; and trunnionosis in plaintiff's hip joint as a result of the premature failure of the device.
 
Manufacturer Narrative
It has been identified that this report represents a duplicate of a prior case, previously reported via mdr 3005975929-2016-00043.Please therefore disregard this incident report.
 
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Brand Name
BHR ACETABLR CUP
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
MDR Report Key7865565
MDR Text Key119858787
Report Number3005975929-2018-00315
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 other
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/30/2018
Initial Date FDA Received09/11/2018
Supplement Dates Manufacturer Received08/30/2018
Supplement Dates FDA Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; BHR MODULAR SLEEVE / UNKNOWN LOT NUMBER; UNKNOWN HIP IMPLANT/ UNKNOWN LOT NUMBER; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; BHR MODULAR SLEEVE / UNKNOWN LOT NUMBER; UNKNOWN HIP IMPLANT/ UNKNOWN LOT NUMBER
Patient Outcome(s) Hospitalization; Required Intervention;
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