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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G311
Device Problem Material Discolored (1170)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Injury (2348)
Event Date 06/14/2018
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 no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.

 
Event Description

The patient underwent primary tka surgery with triathlon in (b)(6) 2018. After the surgery, the patient claimed pain and limited range of motion. Treatment for synovitis was performed under arthroscopy. Then, open surgery was performed to resect the posterior synovial membrane on (b)(6) 2018 and the insert was also replaced. The removed inserted had turned yellow as a whole.

 
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Brand NameX3 TRIATHLON CS INSERT #3 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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7682074
MDR Text Key113786460
Report Number0002249697-2018-02150
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,Followup
Report Date 08/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G311
Device LOT NumberLHA601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/07/2017
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: 07/12/2018 Patient Sequence Number: 1
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