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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, FEMORAL, RESURFACING Back to Search Results
Catalog Number 74123152
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Hip Fracture (2349)
Event Date 08/24/2017
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to femoral neck fracture.The patient reported pain after implantation and an x-ray confirmed a fracture.
 
Manufacturer Narrative
[(b)(4)].
 
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Brand Name
BHR RESURFACING FEMORAL HEAD 52MM
Type of Device
PROSTHESIS, HIP, FEMORAL, 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 Key6900044
MDR Text Key87599783
Report Number3005975929-2017-00337
Device Sequence Number1
Product Code KXA
UDI-Device Identifier03596010552433
UDI-Public03596010552433
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 company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74123152
Device Lot Number16CW10999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACETABULAR CUP, # (B)(4), LOT # 16GW03711
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
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