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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 71356103
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Bone Fracture(s) (1870); No Code Available (3191)
Date of Event 07/10/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during implantation of femoral device in total hip arthroplasty a non-displaced proximal femur fracture occured.Cable was used to resolved this issue and the severity was deemed as mild.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
ANTHOLOGY HO POROUS SZ 3
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6773581
Report Number1020279-2017-00604
Device Sequence Number163380
Product Code JDI
UDI-Device Identifier03596010567857
UDI-Public03596010567857
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K052792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/10/2017
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
Operator of Device Health Professional
Device Expiration Date01/10/2020
Device Model Number71356103
Device Catalogue Number71356103
Device Lot Number10HM14207
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/10/2017
Supplement Date Received by Manufacturer07/10/2017
Initial Report FDA Received Date08/08/2017
Supplement Report FDA Received Date10/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
Patient Weight72
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