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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SCORPIO TIBIAL BASEPLATE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number UNK_JR
Device Problem Crack (1135)
Patient Problem Injury (2348)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative

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. Device not returned.

 
Event Description

It was reported that the patient's left knee was revised due to a cracked tibial baseplate. The surgeon could offer no possible explanation as to how the baseplate came to be cracked. Intra- operatively, the insert was observed to be worn. There were no allegations against the femoral component. The patient's scorpio ps construct was revised in toto to a triathlon ts insert. Rep reported that no further information will be available.

 
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Brand NameUNKNOWN SCORPIO TIBIAL BASEPLATE
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9452546
MDR Text Key182965026
Report Number0002249697-2019-04001
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
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: 12/11/2019 Patient Sequence Number: 1
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