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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP
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SMITH & NEPHEW BHR; ACETABULAR CUP Back to Search Results
Catalog Number 74120152
Device Problem Metal Shedding Debris (1804)
Patient Problems Pain (1994); Seroma (2069); Weakness (2145); Toxicity (2333)
Event Date 08/07/2014
Event Type  Injury  
Event Description
It was reported that revision surgery of the right hip was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations around the hip were reported.
 
Manufacturer Narrative
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
michael simmonds
4419264823
MDR Report Key4336856
MDR Text Key5215673
Report Number3005477969-2014-00597
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2014
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
Device Catalogue Number74120152
Device Lot Number077157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/10/2014
Initial Date FDA Received12/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL STEM, # 71291651, LOT # 06BAB0007A; HEMI HEAD, # 74122546, LOT # 07DW11338; HEMI HEAD, # 74122546, LOT # 07DW11338; MODULAR SLEEVE, # 74222200, LOT # 07FW12479
Patient Outcome(s) Hospitalization; Required Intervention;
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