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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CEMENT ACET COM 22/43; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. REF CEMENT ACET COM 22/43; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71352243
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Failure of Implant (1924); Joint Dislocation (2374)
Date of Event 11/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that surgeon does not consider this to be a product complaint.
 
Event or Problem Description
It was reported that patient underwent a revision surgery of hip arthroplasty due to repeated dislocation.
 
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Brand Name
REF CEMENT ACET COM 22/43
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7058438
Report Number1020279-2017-01116
Device Sequence Number1119627
Product Code LPH
UDI-Device Identifier03596010198051
UDI-Public03596010198051
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K932755
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/27/2017
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 Date12/29/2011
Device Catalogue Number71352243
Device Lot Number01MT66376
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2017
Initial Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SS12/14 TPR FEM HD 22MM+0, 71292200/05LT93750
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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