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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5530-G-513
Device Problems Device Dislodged or Dislocated (2923); Scratched Material (3020)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative

Reported event: an event regarding pain involving a triathlon insert was reported. The event was not confirmed. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Device not returned.

 
Event Description

It was reported that patient's left knee was revised due to pain. An a35 patella and 5x13 cr insert were revised to an a38 patella and 5x16 cr insert. Rep provided a primary operative note, webops report of the primary implants, examination note, pre-revision x-rays, and a picture of the explants and reported that all available information has been submitted. Update: x-ray from (b)(6) 2018 show lateral patella subluxation of the left knee.

 
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Brand NameTRIATHLON CR X3 TIBIAL INSERT
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8126688
MDR Text Key129152432
Report Number0002249697-2018-03890
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2014
Device Catalogue Number5530-G-513
Device LOT NumberMHD2JW
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/03/2018 Patient Sequence Number: 1
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