MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS MODULAR DISTAL CAPTURE; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 6541-5-723

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

During a primary total knee (left side), when the surgeon removed the mis modular capture, the device came apart in 4 separate pieces.No adverse consequence to patient or user.Surgery completed without any delay or interruption.

Manufacturer Narrative

An event regarding subcomponent dissociation involving a triathlon modular distal capture was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the event.Medical records received and evaluation: not performed as it was reported there was no impact to the patient associated with the event.Device history review: not performed as the device was determined to be not manufactured to specification.Complaint history review: there have been no other events for the reported lot.Conclusions: the reported event was confirmed.A material analysis performed for the same product and issue found no evidence on the pins to indicate press-fit conditions.Examination with the material analysis team confirmed the subject device to be within the scope of an nc that was raised with the supplier to address the observed nonconformance.

Event Description

During a primary total knee (left side), when the surgeon removed the mis modular capture, the device came apart in 4 separate pieces.No adverse consequence to patient or user.Surgery completed without any delay or interruption.

• Brand Name: MIS MODULAR DISTAL CAPTURE
• Type of Device: KNEE 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5038607
• MDR Text Key: 25142632
• Report Number: 0002249697-2015-02831
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-5-723
• Device Lot Number: AF3V02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 102