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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-509
Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 07/01/2011
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: triathlon prim cem fxd bplt #5; cat# 5520-b-500; lot# stbjk. Triathlon asymmetric x3 patella; cat# 5551-g-350; lot# a168. Triathlon p/a ps beaded #5r; cat# 5516-f-502; lot# styjn. Simplex p speedset full dose 1 pack; cat# 6192-1-001; lot# dlr032. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

After rehab everything was fine riding bikes etc. Four months later his knee buckled. Went back to therapy. They used heating pads. Thirty minutes later he had major pain. His primary doctor sent him for a cat scan. Found out the knee was actually loose. Patient uses ace bandage to hold it together. Update 5/4/2016: patient stated that he had a right knee replacement on (b)(6) 2011. Patient stated that approximately 4 months after his surgery, he experienced pain and trouble going up and down stairs. Pain persists until now.

 
Manufacturer Narrative

An event regarding pain involving a triathlon insert component was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as product was not returned. -medical records received and evaluation: insufficient medical records were received for review. -device history review: review of the dhr was satisfactory. -complaint history review: review of the chr confirmed that there were no other similar events for the lot. Conclusions: clinician review of the available medical records indicated: regarding the 2016 complaints, there is a bone scan from 2015, that was "hot" but such findings are difficult to interpret if no context with other information is available. There is one radiological report that speaks about a small radiolucent line but also this is not complete and therefore it is not certain the baseplate was loose. Even if loose, the cause would be unclear because no other info is available to answer that question. X-rays are missing while also the records do not give any info as to what might have caused the problem and therefore this case can unfortunately not be solved with the available information. No further investigation is possible with the information received. Further information such as product evaluation, patient history, medical records, operative notes and x-rays are needed to complete the investigation for determining a root cause. A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

After rehab everything was fine riding bikes etc. 4 months later his knee buckled. Went back to therapy. They used heating pads. Thirty minutes later he had major pain. His primary doctor sent him for a cat scan. Found out the knee was actually loose. Patient uses ace bandage to hold it together. Update 5/4/2016: patient stated that he had a right knee replacement on (b)(6) 2011. Patient stated that approximately 4 months after his surgery, he experienced pain and trouble going up and down stairs. Pain persists until now.

 
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Brand NameTRIATHLON PS X3 TIBIAL INSERT
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-LIMERICK
raheen business park
limerick NJ NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5646850
MDR Text Key44983385
Report Number0002249697-2016-01559
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device Catalogue Number5532-G-509
Device LOT NumberMJTT4R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/11/2016 Patient Sequence Number: 1
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