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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 02/02/2017
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. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

This pi is for the revision of the patient's right knee on (b)(6) 2017. Procedure: the patient had a history of infected right knee replacement outside cors scope. Patient underwent resection arthroplasty with antibiotic cemet spacer to treat the infection (b)(6) 2016 off-label. Patient had second stage infection right total knee replacement (b)(6) 2016. Patient had mechanical problem right total knee revision surgery (b)(6) 2017 resection arthroplasty. Patient underwent chronically infected total knee arthroplasty revision with femoral component and patellar component (b)(6) 2019.

 
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Brand NameUNKNOWN TRIATHLON KNEE
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9213156
MDR Text Key166951947
Report Number0002249697-2019-03551
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
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 Received09/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/21/2019 Patient Sequence Number: 1
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