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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 6RT; PRSTHSIS KNEE PATLLOFMRTIBA SEMICONSTRAINED UNCMNTD PROUS COATED POLYMETALPOLY
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SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 6RT; PRSTHSIS KNEE PATLLOFMRTIBA SEMICONSTRAINED UNCMNTD PROUS COATED POLYMETALPOLY Back to Search Results
Catalog Number 71422032
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/06/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant instability.Delay of 30min reported.Replaced with s&n components.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
GII C/R HA POROUS FEM SZ 6RT
Common Device Name
PRSTHSIS KNEE PATLLOFMRTIBA SEMICONSTRAINED UNCMNTD PROUS COATED POLYMETALPOLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8201277
Report Number1020279-2018-02932
Device Sequence Number16452450
Product Code MBH
UDI-Device Identifier03596010512475
UDI-Public03596010512475
Combination Product (Y/N)N
PMA/510(K) Number
K030612
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/22/2019
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 Number71422032
Device Lot Number16DM02817
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 12/06/2018
Supplement Date Received by Manufacturer12/06/2018
Initial Report FDA Received Date12/27/2018
Supplement Report FDA Received Date03/22/2019
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;
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