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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #3L; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #3L; IMPLANT Back to Search Results
Catalog Number 5516F301
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 12/19/2014
Event Type  Injury  
Event Description
Patient had primary of left knee.The doctor noticed intraoperatively, a crack in femur.He stated it was not caused by instrument or implant.The doctor went ahead and fix femur and surgery was completed with no adverse consequences to patient.
 
Manufacturer Narrative
It was noted that the device and additional medical records are not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
 
Manufacturer Narrative
The patient is (b)(6).An event regarding intra-operative crack/fracture of the patient's femur involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: medical review was not performed as medical records were not provided.-device history review: dhr review was satisfactory.-complaint history review: chr review confirmed that there were no other events reported for the lot.Conclusions: the event cannot be confirmed with the limited information provided.The exact cause of the event cannot be determined without x-rays, operative reports and patient history.
 
Event Description
Patient had primary of left knee.The doctor noticed intraoperatively, a crack in femur.He stated it was not caused by instrument or implant.The doctor went ahead and fix femur and surgery was completed with no adverse consequences to patient.
 
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Brand Name
TRIATHLON P/A PS BEADED #3L
Type of Device
IMPLANT
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4416614
MDR Text Key18267833
Report Number0002249697-2015-00079
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Catalogue Number5516F301
Device Lot NumberEJ83N
Other Device ID NumberSTER LOT R7125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
Patient Weight80
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