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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A32 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A32 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5554L320
Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative

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. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. Based on the device identification the complaint databases were reviewed for similar reported events regarding loosening. There have been no other events for the lot referenced.

 
Event Description

As reported through mw5078695 "patient reports she was unable to get up from her bed one morning due to severe pain in her knee. She reports hearing clicks while walking and has experienced weakness, swelling and buckling. Her orthopedic surgeon saw "something sticking out of her bone" and mentioned that "something pulls away" when she moves her knee. The patient is wearing a knee brace for support and can no longer hear the clicking noise; however, her other symptoms persist" update (b)(6) 2018: right knee loosening.

 
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Brand NameTRIATHLON MB PATELLA PA A32
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8105554
MDR Text Key128397111
Report Number0002249697-2018-03824
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device Catalogue Number5554L320
Device LOT NumberSY4KA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/05/2011
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: 11/27/2018 Patient Sequence Number: 1
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