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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON NO 7 TIB INSERT A/P B/UP 13MM; KNEE IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON NO 7 TIB INSERT A/P B/UP 13MM; KNEE IMPLANT Back to Search Results
Catalog Number C-M052-7-902
Device Problems Crack (1135); Fracture (1260); Delamination (2904)
Patient Problem Injury (2348)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate this custom device was manufactured and accepted into final stock with no relevant reported discrepancies.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.Device not returned.
 
Event Description
Revision of a triathlon knee was performed.Patient primary surgery was reportedly performed in (b)(6).Poly insert was found to be damaged.Surgeon found instability to be a concern so femur was revised to address improved stability.
 
Event Description
Revision of a triathlon knee was performed.Patient primary surgery was reportedly performed in (b)(6).Poly insert was found to be damaged.Surgeon found instability to be a concern so femur was revised to address improved stability.
 
Manufacturer Narrative
An event regarding instability(varus/valgus laxity) and implant damage involving a custom insert was reported.The damage to the insert was confirmed through the images provided.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted custom triathlon poly insert.The posterior of one of the two condyles shows delamination resulting in a crack of the polyethylene outer layer consistent with wear of the bearing surface most likely caused by posterior edge loading from the femoral component.On the lateral aspect of the bearing surface of one of the compartments, damage is observed, however, the cause of this damage cannot be determined.Damage consistent with explantation is also visible on the underside of the insert.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the device was free from discrepancies when released.Complaint history review: not applicable as this is a custom device.Conclusions: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted custom triathlon poly insert.The posterior of one of the two condyles shows delamination resulting in a crack of the polyethylene outer layer consistent with wear of the bearing surface most likely caused by posterior edge loading from the femoral component.On the lateral aspect of the bearing surface of one of the compartments, damage is observed, however, the cause of this damage cannot be determined.Damage consistent with explantation is also visible on the underside of the insert.While the event could be confirmed through the explant images provided, the root cause could not be determined because the insufficient medical information was provided.Further information such as x-rays, medical records, return of device, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
 
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Brand Name
TRIATHLON NO 7 TIB INSERT A/P B/UP 13MM
Type of Device
KNEE IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7356949
MDR Text Key103014324
Report Number0002249697-2018-00800
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2012
Device Catalogue NumberC-M052-7-902
Device Lot NumberRX5279C
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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