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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 1; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 1; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64813110
Medical Device Problem Codes Break (1069); Fracture (1260)
Health Effect - Clinical Code Injury (2348)
Date of Event 01/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event or Problem Description
Patient had a revision surgery due to fracture of the tibial baseplate.
 
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Brand Name
MRH TIBIAL B/PLT KEEL SML 1
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8378849
Report Number0002249697-2019-01218
Device Sequence Number14144578
Product Code KRO
UDI-Device Identifier07613327045307
UDI-Public07613327045307
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K002552
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 02/28/2019
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 Expiration Date04/30/2016
Device Catalogue Number64813110
Device Lot NumberS3X7N
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/01/2019
Initial Report FDA Received Date02/28/2019
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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