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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ3 LEFT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ3 LEFT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5512-F-301
Device Problem Loss of Osseointegration (2408)
Patient Problem Injury (2348)
Event Date 02/24/2020
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. Device not returned.

 
Event Description

This pi is for the knee revision due to loosening and impingement on (b)(6) 2020. Postoperative diagnosis: the patient had a history of left knee replacement (outside of cors scope). Patient underwent knee revision for mechanical problem (b)(6) 2017. The patella was retained. The patient underwent left knee replacement revision of femoral components and polyethylene (b)(6) 2019. Reported as cors per 8200knee ((b)(4)). Patient was failed left total knee arthroplasty secondary to loosening and impingement of femoral component. Patient underwent new revision of left total knee arthroplasty (b)(6) 2020. Femoral components and polyethylene where exchanged.

 
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Brand NameTRI TS FEMUR SZ3 LEFT
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10479494
MDR Text Key205285819
Report Number0002249697-2020-01776
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
Reporter Occupation
Type of Report Initial
Report Date 09/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2020
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5512-F-301
Device Catalogue Number5512-F-301
Device LOT NumberAZV9B
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 Received08/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2017
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: 09/01/2020 Patient Sequence Number: 1
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