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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ4 - 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ4 - 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-T-409B
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2017
Event Type  Malfunction  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

Tibial trial insert broke while inserting to trial with the final implants.

 
Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported. The event was confirmed. Method & results: -device evaluation and results:the device will not be returned for evaluation. Review of photographs were reviewed by a materials sme, who concluded that the device shows numerous indentations from repeated use, and that the fracture does not appear to be along the part¿s knit line and therefore not related to lack of material fusion at the knit line. Further communication: "from the images provided, overload would be the most likely fracture mode. " -medical records received and evaluation: no medical records or x-rays were made available for evaluation. -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. -complaint history review: there has been no other events for the lot referenced. Conclusions: the event was confirmed. A review of the photo provided was conducted by a materials sme, who concluded that the device shows numerous indentations from repeated use, and that the fracture does not appear to be along the part¿s knit line and therefore not related to lack of material fusion at the knit line. Further communication with material analysis engineer: "from the images provided, overload would be the most likely fracture mode. " -medical records received and evaluation: no medical records or x-rays were made available for evaluation. ".

 
Event Description

Tibial trial insert broke while inserting to trial with the final implants.

 
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Brand NameTRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ4 - 9MM
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
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6363158
MDR Text Key68752085
Report Number0002249697-2017-00689
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033716
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 05/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5530-T-409B
Device LOT NumberKMAWM5
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 Received04/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2016
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: 02/27/2017 Patient Sequence Number: 1
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