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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, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A32 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5554L320
Device Problems Fracture (1260); Material Integrity Problem (2978); Torn Material (3024)
Patient Problems Pain (1994); Injury (2348)
Event Date 05/20/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Patient complained of knee pain. Open surgery revealed fractured patellar component.

 
Manufacturer Narrative

An event regarding fracture involving a triathlon patellar component was reported. The event was confirmed from the photographs provided. Method & results: -device evaluation and results: photographs of the patellar component were provided. There is a portion of the articulating surface that appears somewhat "torn" from the component but not fully detached. There appears to be tissue or bone cement protruding from the other side (metal-back) of the component. -medical records received and evaluation: insufficient medical records were provided for review. -device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. -complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot. Conclusion: photographs of the patellar component were provided. There is a portion of the articulating surface that appears somewhat "torn" from the component but not fully detached. There appears to be tissue or bone cement protruding from the other side (metal-back) of the component. The exact cause of the event could not be determined because insufficient information was provided. Further information such as further x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient complained of knee pain. Open surgery revealed fractured patellar component.

 
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Brand NameTRIATHLON MB PATELLA PA A32
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5732499
MDR Text Key47623700
Report Number0002249697-2016-01972
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,Followup
Report Date 05/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2013
Device Catalogue Number5554L320
Device LOT NumberSF8DT
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 Received07/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2008
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: 06/17/2016 Patient Sequence Number: 1
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