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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a right sided tka on (b)(6) 2017 and during this procedure the surgeon utilized simplex g-hv bone cement to cement all the components. It is further alleged that on (b)(6) 2019 she underwent a right sided revision and the operative notes show that the tibial component was loose. It is alleged that this aseptic loosening and debonding of the tibial components resulted from the simplex g-hv bone cement.

 
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Brand NameUNKNOWN 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10547542
MDR Text Key207353004
Report Number0002249697-2020-01927
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
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: 09/17/2020 Patient Sequence Number: 1
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