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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-411
Device Problem Insufficient Information (3190)
Patient Problems Edema (1820); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Injury (2348); Fibrosis (3167)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
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
My husband had a knee replacement done in (b)(6) 2017 and for several months had swelling, instability and severe pain.Then he ended up having a revision done on (b)(6) 2018.Which there is still a lot of pain and swelling.This pi is for revision.
 
Manufacturer Narrative
Additional information: tab d, g and h-device information.An event regarding rom involving an triathlon insert was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed because the device was not returned for analysis.-clinician review: a review of the provided medical records by the consulting clinician indicated "patient underwent a cementless left tka on 03/16/2017.Initially the patent had a normal postoperative course but by 6 months postoperatively he developed an effusion and increased pain in the knee.Initially this was treated conservatively however his symptoms persisted and worsened and a workup including radiographs , bone scan and aspirations was performed seeking a possible infectious or mechanical cause for this problem.The infection workup proved to be negative and his symptoms persisted.On physical exam subtle varus/valgus instability was present and revision surgery was carried out on 02/15/2018.Fresh frozen soft tissue biopsy was obtained at the time of the revision and again no evidence for infection was seen.In addition to the biopsy the revision surgery comprised a thorough synovectomy and exchange to at thicker tibial insert in hopes of increasing knee stability.Post revision the patient continued to complain of severe pain and instability with the knee ¿kicking inwards¿ when he walked.The surgeon report the knee is stable on clinical exam and no evidence for infection, instability or mechanical complication existed.Exists.The patient had range of motion of -20 to 90 degrees.Further physical therapy with stretching and strengthening were recommended." -product history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed by medical review.A review of the medical review revealed that "review of these records confirms pain and stiffness following primary and revision knee surgery most likely due to arthrofibrosis occurred however, the root cause cannot be determined as insufficient information was available.No evidence was for mechanical complication related to the implant was presented." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
My husband had a knee replacement done in march of 2017 and for several months had swelling, instability and severe pain.Then he ended up having a revision done on (b)(6)2018.Which there is still a lot of pain and swelling.This pi is for revision.
 
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Brand Name
TRIATHLON PS X3 TIBIAL INSERT
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 Key7659717
MDR Text Key113064057
Report Number0002249697-2018-02056
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/19/2018
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? No
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Catalogue Number5532-G-411
Device Lot NumberRD6DP3
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received07/03/2018
Supplement Dates Manufacturer Received08/22/2018
Supplement Dates FDA Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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