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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5537-G-516
Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Scratched Material (3020)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been 2 other events for the lot referenced. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that patient's right knee was revised due to dislocation. Rep reported that no ligament damage was reported. The post of the insert was not locked in to the box opening of the femoral component.

 
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Brand NameNO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7529424
MDR Text Key108743171
Report Number0002249697-2018-01493
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 08/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue Number5537-G-516
Device LOT NumberMMP1AX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/27/2013
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: 05/21/2018 Patient Sequence Number: 1
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