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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71421367
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 08/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to distal thigh pain.During the revision it was discovered the femoral implant was loose.
 
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
LGN HK FEM ASSEMBLY SZ 7 RT
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6861531
Report Number1020279-2017-00739
Device Sequence Number18974141
Product Code KRO
UDI-Device Identifier00885556414927
UDI-Public00885556414927
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K081111
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/01/2017
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 Catalogue Number71421367
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/24/2017
Supplement Date Received by Manufacturer08/24/2017
Initial Report FDA Received Date09/13/2017
Supplement Report FDA Received Date11/01/2017
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 Age79 YR
Patient Weight100
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