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

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.

• Brand Name: TRI PRESS-FIT STEM 17MM X 100MM
• Type of Device: PROSTHESIS, 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 Key: 5542070
• MDR Text Key: 41686108
• Report Number: 0002249697-2016-01046
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 5565-S-017
• Device Lot Number: M8C55A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR