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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G411
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  Malfunction  
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. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

It was reported that, during a tka, after locking the insert, a surgeon noticed a gap(1mm lateral/posterior) between the inset and baseplate. Therefore, he tried to insert another size insert but it was also same condition. The second stayed implanted. Update: the delay time was about 2-3 minutes. Right side.

 
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Brand NameX3 TRIATHLON CS INS SIZE4 11MM
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 Key8939443
MDR Text Key187927192
Report Number0002249697-2019-03010
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
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
Report Date 08/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G411
Device LOT NumberLHE238
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/11/2017
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: 08/28/2019 Patient Sequence Number: 1
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