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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-709
Device Problem Insufficient Information (3190)
Patient Problems Damage to Ligament(s) (1952); Loss of Range of Motion (2032); Injury (2348)
Event Date 04/30/2018
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. Not returned.

 
Event Description

Patient's wife called reporting patient had left knee replacement surgery (b)(6) 2013. Patient began experiencing range of motion issues and was revised on (b)(6) 2018. Patient's wife reports that revising surgeon showed her and her husband pictures of the explanted device, and explained that "the plastic was bubbled" and that the surgeon reported that the device was removed with virtually no resistance or effort, and that the device had severed the patient's medial lateral collateral ligament.

 
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Brand NameTRIATHLON PS X3 TIBIAL INSERT
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 NJ NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8361326
MDR Text Key136853971
Report Number0002249697-2019-01142
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2017
Device Catalogue Number5532-G-709
Device LOT NumberLDA627
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/07/2012
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: 02/22/2019 Patient Sequence Number: 1
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