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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 5630-G-308
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code Injury (2348)
Date of Event 09/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
Revision of left knee.Stryker uni-knee to total knee.Rep stated that this revision might be due to "lateral side wear." rep could not confirm if the wear is specific to the insert.
 
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Brand Name
TRIATHLON PKR INSERT X3 #3 LM/RL -8MM
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9226919
Report Number0002249697-2019-03606
Device Sequence Number1892540
Product Code HRY
UDI-Device Identifier07613327015928
UDI-Public07613327015928
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K082567
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/23/2019
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 Number5630-G-308
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/26/2019
Initial Report FDA Received Date10/23/2019
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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