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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 SZ5 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ5 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-T-511B
Device Problems Crack (1135); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2016
Event Type  malfunction  
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Event Description
Tibial insert trial cracked while trying to insert it after final implants were in.Surgeon noticed it immediately and removed it.The trial remained intact and did not break.An x-ray was taken per hospital protocol and insert was inspected by risk management.There were no adverse consequences or delay in surgery.The surgeon implanted the final implant without incidence.
 
Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis was performed on the returned device that concluded: ¿the fracture occurred in fast fracture through the center of the device.The origin was found to be inside the material at the interface between the first and second injection molding shots.¿ -medical records received and evaluation: there is no indication that patient factors contributed to the reported event.-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 1 other event for the lot referenced.Conclusions: the investigation concluded that the reported device has been identified to be within the scope of nc & capa.The parts are injection molded.Sample parts were pulled from fg.Lack of fusion areas were observed between the first and second shots of the two-shot trials.
 
Event Description
Tibial insert trial cracked while trying to insert it after final implants were in.Surgeon noticed it immediately and removed it.The trial remained intact and did not break.An x-ray was taken per hospital protocol and insert was inspected by risk management.There were no adverse consequences or delay in surgery.The surgeon implanted the final implant without incidence.This event was also reported via user facility mdr report# (b)(4), which stated: while removing the tibial trial insert from the operative knee, the device cracked.The device was removed from the surgical site intact, there was not harm to the patient.Impact to the length of procedure was minute at best.
 
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Brand Name
TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ5 - 11MM
Type of Device
PROSTHESIS, 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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5980880
MDR Text Key56000292
Report Number0002249697-2016-03052
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5530-T-511B
Device Lot NumberKMANN9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age82 YR
Patient Weight169
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