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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MATORTHO LIMITED MEDIAL ROTATION KNEE; TOTAL KNEE REPLACEMENT
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MATORTHO LIMITED MEDIAL ROTATION KNEE; TOTAL KNEE REPLACEMENT Back to Search Results
Catalog Number 156-612
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/01/2011
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Dhr reviewed and labels confirmed as correct.Error at hospital.Report of historical event.The event occured between (b)(6) 2010 and (b)(6) 2013 when k020214 was not listed against any manufacturer.Matortho is making this report to cover this period when the device was not avaialble in the usa for commercial reasons.
 
Event or Problem Description
Patient underwent a left total knee replacement.Following surgery, the scrub nurse identified that a right tibial insert had been used, not a left tibial insert.Patient was informed and revised 1 day post op.
 
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Brand Name
MEDIAL ROTATION KNEE
Common Device Name
TOTAL KNEE REPLACEMENT
Manufacturer (Section D)
MATORTHO LIMITED
13 mole business park
randalls road
leatherhead, surrey KT22 7BA
UK  KT22 7BA
MDR Report Key5385130
Report Number3008985661-2016-00002
Device Sequence Number18868733
Product Code JWH
UDI-Device Identifier05055455503854
UDI-Public5055455503854
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K020214
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2011
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Report Date (Section B) 01/22/2016
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 Physician
Device Catalogue Number156-612
Device Lot Number98334
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/22/2016
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 Required Intervention;
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