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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5526B500
Device Problems Unstable (1667); Malposition of Device (2616); Unintended Movement (3026)
Patient Problem Injury (2348)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative

Reported event: an event regarding revision due to loosening/lack of fixation and instability involving a triathlon baseplate was reported. The instability event was confirmed based on the clinician review. X-rays were not provided, therefore the loosening/lack of fixation was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information. Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability. The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth. All components were removed and replaced with competitor devices including the previously unresurfaced patella. An adverse mix of procedure-related factors regarding component malposition and patient- related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components. Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information. Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability. The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth. All components were removed and replaced with competitor devices including the previously unresurfaced patella. An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components. X-rays and return of the device are needed to further investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. Device not available.

 
Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "left knee, failed total knee arthroplasty. " update to event description based on clinician review of the medical records provided: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information. Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability. The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth. All components were removed and replaced with competitor devices including the previously unresurfaced patella.

 
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Brand NameTRIATHLON PRIM BEAD PA SZE5 BP
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 NA
Manufacturer Contact
margaret foley
raheen business park
limerick NA
61498200
MDR Report Key9151362
MDR Text Key166002594
Report Number0002249697-2019-03365
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
Report Date 10/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2016
Device Catalogue Number5526B500
Device LOT NumberS3K9X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/14/2011
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: 10/03/2019 Patient Sequence Number: 1
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