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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71356102
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/11/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Implant date is an approximation since only the month and year were communicated to us.
 
Event or Problem Description
It was reported that patient underwent a revision surgery due to pain.During surgery the stem was loose and was removed easily and portion of the porous coating had flaked off.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
ANTHOLOGY HO POROUS SZ 2
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6841466
Report Number1020279-2017-00701
Device Sequence Number706180
Product Code JDI
UDI-Device Identifier03596010567840
UDI-Public03596010567840
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K052792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 12/04/2017
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 Date01/31/2020
Device Catalogue Number71356102
Device Lot Number10BM01247
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/11/2017
Supplement Date Received by Manufacturer08/11/2017
Initial Report FDA Received Date09/05/2017
Supplement Report FDA Received Date12/04/2017
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 Hospitalization; Required Intervention;
Patient Weight76
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