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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G109
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Hematoma (1884)
Event Date 10/24/2019
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: tri ts baseplate size 2; cat# 5521-b-200; lot# d914xb. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. 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. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced.

 
Event Description

As reported: "size 1 poly implanted on size 2 universal baseplate. Planned size 1, cut to plan. Dr changed tibia to a 2 due to bone quality (rep confirmed additional cutting was not required). Implants were placed on a small prep table by rep, and nurse circulator held implants up for dr to read labels. Dr. Stopped operating, turned around and slowly read each and every item on label of each implant, and confirmed that is correct, nurse re-read size and expiration to scrub person, then opened implants. " spoke to rep. Patient has developed a significant hematoma and revision surgery is planned to occur on or by (b)(6) 2019. Update: mps was in charge of running this mako tka case. On monday, (b)(6) 2019, jr rep noticed the discrepancy during restocking. The sales sheet was reviewed and it was confirmed that a size 1 femur, size 2 tibia and size 1 tibia polyethylene insert were implanted. Spoke to mps. There are no allegations against the robot or any of the cuts made in the primary procedure. Cause/ contributor for the hematoma not reported.

 
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Brand NameX3 TRIATHLON CS INS SIZE1 9MM
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9364499
MDR Text Key167765497
Report Number0002249697-2019-03851
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G109
Device LOT NumberLFT416
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2017
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: 11/22/2019 Patient Sequence Number: 1
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