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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515-F-602
Medical Device Problem Code Off-Label Use (1494)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/03/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
 
Event or Problem Description
The customer reported implantation of a right triathlon ps femoral component into a left knee on (b)(6) 2017.
 
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Brand Name
TRIATHLON PS FEM COMPONENT, CEMENTED
Common Device Name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7402657
Report Number0002249697-2018-01023
Device Sequence Number1950047
Product Code MBH
UDI-Device Identifier07613327050424
UDI-Public07613327050424
Combination Product (Y/N)N
PMA/510(K) Number
K141056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source distributor,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/31/2021
Device Catalogue Number5515-F-602
Device Lot NumberBRB2J
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/06/2018
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 Other;
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