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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Joint Dislocation (2374)
Event Type  Injury  
Event Description
It was reported that right hip revision surgery was performed in or about 2009, with a subsequent revision in or about 2011.Devices implanted april 2008.Pain, loss of mobility, dislocation, joint instability, pain during movements, inflammation and soreness around the implanted, user annoyance, pain associated with implant loosening, and leg length discrepancy reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
BHR ACETABULAR CUP
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
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key7070084
MDR Text Key93285389
Report Number3005975929-2017-00425
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL HEAD, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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