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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5537-G-616
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
The surgeon reported that the triathlon ts 19mm insert wouldn¿t sit correctly in universal base plate.He further reported that he then inserted the ts 16mm insert into the universal tibial base plate, again this didn¿t seat properly, he impacted the liner again and inserted the post and said that he would bring patient back to theatre next day for a liner exchange.There was a 10 minute delay to surgery.
 
Event Description
The surgeon reported that the triathlon ts 19mm insert wouldn¿t sit correctly in universal base plate.He further reported that he then inserted the ts 16mm insert into the universal tibial base plate, again this didn¿t seat properly, he impacted the liner again and inserted the post and said that he would bring patient back to theatre next day for a liner exchange.There was a 10 minute delay to surgery.Update: per communication received, the patient had the liner revised on (b)(6) 2018.
 
Manufacturer Narrative
An event regarding a triathlon baseplate that a 19 mm and 16 mm triathlon insert would not seat into position was reported.The event could not be confirmed.Device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: not performed because no patient clinical information was provided.The reported device was manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events reported for this manufacturing lot.It was reported by the surgeon that the triathlon ts 19mm insert wouldn¿t sit correctly in universal base plate.He further reported that he then inserted the ts 16mm insert into the universal base tibial base plate, again this didn¿t seat properly, he impacted the liner again and inserted the post and said that he would bring patient back to theatre next day for a liner exchange.There was a 10 minute delay to surgery.The patient returned to surgery the next day and underwent liner exchange only, he exposed the whole of the tibial tray and inserted the new ts 19mm liner.The event itself could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided and the device was not returned (the baseplate remains implanted).Further information such as product evaluation, pre- and post-operative x-rays, operative reports as well as follow-up notes are needed to complete the investigation for determining a root cause.It is noted that the 19 mm insert was inserted the following day with no reported issues.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
 
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Brand Name
NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7277372
MDR Text Key100292186
Report Number0002249697-2018-00457
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327027419
UDI-Public07613327027419
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Catalogue Number5537-G-616
Device Lot NumberYK6273
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/22/2018
Initial Date FDA Received02/16/2018
Supplement Dates Manufacturer Received02/28/2018
Supplement Dates FDA Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age73 YR
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