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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-T-411A
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Two plastic trials were chipped during the operation.

 
Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert trial was reported. The event was confirmed. Method & results: -device evaluation and results: examination of the returned device with material analysis engineer indicated the fracture is consistent with overload condition. -medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated "there are no serial x-rays confirming a loose femoral component which required osteotomes for removal at revision surgery and no mention of broken trials in the operative report. There is no examination of the broken trials or indication if they broke when forcibly impacted into the tibial tray. There is no evidence that factors of faulty component or component trial design, manufacturing or materials were responsible for this clinical situation. " -device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other events for this lot. Conclusions: the investigation concluded that the reported event occurred as a result of overload conditions during trialing. No further investigation for this event is possible at this time. If additional information become available, this investigation will be reopened and re-evaluated.

 
Event Description

Two plastic trials were chipped during the operation.

 
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Brand NameMODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 11MM
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6382276
MDR Text Key69493341
Report Number0002249697-2017-00789
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
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 05/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-T-411A
Device LOT NumberPPM3A40
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/04/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/06/2017 Patient Sequence Number: 1
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