MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EIUS UNI KNEE SML FEM RM/LL; IMPLANT

Catalog Number 66362012

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 01/03/2006

Event Type  Injury  

Event Description

Patient had a primary partial knee surgery in (b)(6) 2006.Patient began to experience severe pain.Around (b)(6), the surgeon ordered an x-ray and stated that pain could be due to scar tissue.The patient than had a scope done on (b)(6) 2006 and it was found that a screw was loose due to a bad mixture of glue.Patient was scheduled for revision surgery on (b)(6) 2006.

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.Device not returned to manufacturer.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding loosening involving an eius femoral component was reported.The event was confirmed.Method and results: device evaluation and results: not performed as no devices were returned.Medical records received and evaluation: in this morbidly obese patient with chronic pain and narcotic dependence there is no evidence that faulty unicondylar knee arthroplasty components or cement were responsible for her symptoms that resulted in multiple surgeries and subsequent infection of her right knee.At last follow up her right total knee arthroplasty appears to be among the most asymptomatic sites in her body.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined based on the information provided.No x-rays of the unicondylar right knee are available.The medical review indicates that there is no evidence that faulty unicondylar knee arthroplasty components or cement were responsible for her symptoms that resulted in multiple surgeries.It is noted that a product field action in the form of a reportable product recall was initiated for eius knee components and that the eius knee system was made obsolete in february 2011.

Event Description

Patient had a primary partial knee surgery in (b)(6) 2006.Patient began to experience severe pain.Around (b)(6) the surgeon ordered an x-ray and stated that pain could be due to scar tissue.The patient than had a scope done on (b)(6) 2006 and it was found that a screw was loose due to a bad mixture of glue.Patient was scheduled for revision surgery on (b)(6) 2006.

• Brand Name: EIUS UNI KNEE SML FEM RM/LL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3807935
• MDR Text Key: 16915528
• Report Number: 0002249697-2014-01810
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 66362012
• Device Lot Number: L4XUL
• Other Device ID Number: STERILE LOT# F4149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2005
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 113