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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
Model Number 5532-G-609
Device Problem Insufficient Information (3190)
Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)
Event Date 11/24/2015
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. The following devices were also listed in this report: triathlon asymmetric x3 patella; cat # 5551-g-350; lot # 7kw6. Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot # hjzld. Triathlon ps fem component, cemented; cat # 5515-f-602; lot # iaubd. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

 
Event Description

Based on the medical review the patient underwent right knee arthroplasty on (b)(6) 2013. Right knee x-rays documented abnormal calcification near the inferior pole of the patella. With persistent complaints it was decided to remove this calcification and this was performed on (b)(6) 2015. Arthrotomy was performed with removal of the bony ossicle and partial lateral release of the patella.

 
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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 NA
NA
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood, NJ WD6 3-SJ
GB   WD6 3SJ
2018315000
MDR Report Key9997914
MDR Text Key189295012
Report Number0002249697-2020-00801
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2017
Device MODEL Number5532-G-609
Device Catalogue Number5532-G-609
Device LOT NumberMLPW1M
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2012
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: 04/24/2020 Patient Sequence Number: 1
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