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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5532-G-411
Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
Event Date 10/18/2019
Event Type  Injury  
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 similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Information received in follow-up includes an operative report for a right knee revision on (b)(6) 2019. Noted in the records are the following: ". Fell in the bathtub. She had immediate pain. Continued to have pain and disability. Found to have a rupture patellar tendon. Failed right total knee arthroplasty with dislocation of the prosthesis. Instability of her prosthetic joint. " a size 4 primary baseplate (implanted (b)(6) 2009) and a 4x11 ps insert (implanted (b)(6) 2018) were revised to a size 4 universal baseplate with stem and augments, and a 4x13 ts insert.

 
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Brand NameTRIATHLON PS X3 TIBIAL INSERT
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10206456
MDR Text Key198137352
Report Number0002249697-2020-01320
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5532-G-411
Device Catalogue Number5532-G-411
Device LOT NumberXR7T2W
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 Received07/31/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/24/2018
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: 06/29/2020 Patient Sequence Number: 1
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