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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 17MM X 100MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 17MM X 100MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5565-S-017
Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Metal Shedding Debris (1804)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 03/09/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available, it will be reported in a supplemental report upon completion of the investigation. Device not returned to the manufacturer.

 
Event Description

Patient had two previous revisions and a primary knee prior. Dr (b)(6) performed previous surgeries. The prior knee revision was the femoral component side only and it was revised, this most recent ((b)(6) 2016) as well. Patient had a fractured patella and pain. Upon exposure it was noted a great deal of metal debris. Further examination of x-ray showed loosening of femoral components. Upon extraction of femoral component it was noted stem was unthreaded partially from femoral component. New implants were placed in femur. This report is for the third revision on (b)(6) 2016. The patient was revised due to loosening. Patella bone fracture was noticed on x-rays prior to revision surgery on (b)(6) 2016.

 
Manufacturer Narrative

An event regarding loosening involving a tri press-fit stem 17mm x 100mm was reported. The event was not confirmed. Method and results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned. Medical records received and evaluation: ¿in this markedly obese patient there is no convincing radiographic or intraoperative evidence of symptomatic loosening of the components. The patellar fracture as a result of direct impact trauma was unrelated to the prosthesis. There is no evidence this patient¿s clinical problems were related to factors of faulty component design, manufacturing or materials. ¿ device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the investigation concluded that based on the medical review, ¿in this markedly obese patient there is no convincing radiographic or intraoperative evidence of symptomatic loosening of the components. The patellar fracture as a result of direct impact trauma was unrelated to the prosthesis. There is no evidence this patient¿s clinical problems were related to factors of faulty component design, manufacturing or materials. ¿.

 
Event Description

Patient had two previous revisions and a primary knee prior. Dr. (b)(6) performed previous surgeries. The prior knee revision was the femoral component side only and it was revised, this most recent ((b)(6) 2016) as well. Patient had a fractured patella and pain. Upon exposure it was noted a great deal of metal debris. Further examination of x-ray showed loosening of femoral components. Upon extraction of femoral component it was noted stem was unthreaded partially from femoral component. New implants were placed in femur. This report is for the third revision on (b)(6) 2016. The patient was revised due to loosening. Patella bone fracture was noticed on x-rays prior to revision surgery on (b)(6) 2016.

 
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Brand NameTRI PRESS-FIT STEM 17MM X 100MM
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5542070
MDR Text Key41686108
Report Number0002249697-2016-01046
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,Followup
Report Date 03/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue Number5565-S-017
Device LOT NumberM8C55A
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 Received05/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2013
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: 04/01/2016 Patient Sequence Number: 1
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