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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 RIGHT; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
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SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 RIGHT; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR Back to Search Results
Catalog Number 71420150
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/11/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to posterior cruciate ligament injury.The surgeon considered it is not the product failure.
 
Additional Manufacturer Narrative
Additional info: the associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.
 
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Brand Name
GII OXINIUM FEM SIZE 4 RIGHT
Common Device Name
PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7128118
Report Number1020279-2017-01283
Device Sequence Number977695
Product Code JWH
UDI-Device Identifier03596010430175
UDI-Public03596010430175
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K962557
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/27/2018
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 Number71420150
Device Lot Number17AM13089
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/12/2017
Supplement Date Received by Manufacturer12/12/2017
Initial Report FDA Received Date12/19/2017
Supplement Report FDA Received Date02/27/2018
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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