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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G309
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348)
Event Date 07/24/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
Patient was having pain and decreased range of motion in her right knee.Dr.(b)(6) decided to explore the knee.Quite a bit of scar tissue was removed during the operation, but nothing was found wrong with the knee or the alignment.Dr.(b)(6) decided to change the poly insert and also removed some osteophytes off the posterior condyles.
 
Manufacturer Narrative
An event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: there is no indication this case of post-operative arthrofibrosis was related to factors of implant design, manufacturing or materials.Arthrofibrosis is, unfortunately, a commonly reported complication of all total knee arthroplasties.Product history review: indicated 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 lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: there is no indication this case of post-operative arthrofibrosis was related to factors of implant design, manufacturing or materials.Arthrofibrosis is, unfortunately, a commonly reported complication of all total knee arthroplasties.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Patient was having pain and decreased range of motion in her right knee.Dr.(b)(6) decided to explore the knee.Quite a bit of scar tissue was removed during the operation, but nothing was found wrong with the knee or the alignment.Dr.(b)(6) decided to change the poly insert and also removed some osteophytes off the posterior condyles.
 
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Brand Name
X3 TRIATHLON CS INSERT #3 9MM
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 Key7802750
MDR Text Key117789434
Report Number0002249697-2018-02625
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327045727
UDI-Public07613327045727
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 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Catalogue Number5531G309
Device Lot NumberLER120
Was Device Available for Evaluation? No
Date Manufacturer Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age49 YR
Patient Weight102
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