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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIB LM/RL TIB AUG SZ3 10MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TIB LM/RL TIB AUG SZ3 10MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5546-A-301
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 12/26/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding tibial loosening involving a triathlon augment was reported. The event was not confirmed. Method & results: product evaluation and results: not performed as no product was returned for evaluation. Clinician review: not performed as medical records were not provided. Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. Not returned to the manufacturer.

 
Event Description

As reported: "patient's left tibial component was revised due to loosening¿all tibial components (12x50 stem, size 3 universal baseplate, two augments, 3x16 ts insert)¿were explanted and revised to triathlon ts. Tibial side as a whole was loosened, no specific implant(s) cited. ".

 
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Brand NameTIB LM/RL TIB AUG SZ3 10MM
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8265295
MDR Text Key133705071
Report Number0002249697-2019-00238
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
Report Date 01/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2014
Device Catalogue Number5546-A-301
Device LOT NumberN4E32D
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 Received12/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2009
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: 01/21/2019 Patient Sequence Number: 1
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