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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ TRIATHLON KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348)
Event Date 03/23/2016
Event Type  Injury  
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. Device not returned.

 
Event Description

Patient's daughter stated, her mother had a right tka performed on (b)(6) 2016, she had a blood clot right after surgery which prevented her from starting physical therapy for about 2 - 3 weeks. She was never able to regain her range of motion, unable to walk and has been experiencing pain since her surgery. Patient has had a year of physical therapy and became addicted to oxycodone due to the pain and had to get weaned of it. The patient seeked a second opinion and from the mris and x-rays images was told that her knee was loose, fitted improperly and also her implants were recalled. The patient was revised on (b)(6) 2017 and has been asymptomatic since. Patient is seeking compensation.

 
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Brand NameUNKNOWN_ TRIATHLON KNEE
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 Key10459552
MDR Text Key204548008
Report Number0002249697-2020-01750
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/27/2020 Patient Sequence Number: 1
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