MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS MODULAR DISTAL CAPTURE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-5-723

Device Problems Disassembly (1168); 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 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during a tka, the reported device was disassembled.There was no health damage on this event.The device was shipped to the customer before product hold.

Manufacturer Narrative

An event regarding an alleged disassembly issue involving a modular distal capture was reported.The event was confirmed.Method & results: device evaluation and results: a visual analysis confirmed the device was returned in used condition.The pin, spring, locking knob and body were separated.Dimensional inspection indicated the pin was undersized.Medical records received and evaluation: not performed as no medical records were provided.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the pin subcomponent was undersized and exhibited a lack of press-fit with the locking knob.Nc was initiated on (b)(6) 2015 for a lack of press-fit between the pin and locking knob subcomponents of triathlon mis modular distal captures.The root cause was determined to be that the supplier was manufacturing the pins in an undersized condition.

Event Description

It was reported that, during a tka, the reported device was disassembled.There was no health damage on this event.The device was shipped to the customer before product hold.

• Brand Name: MIS MODULAR DISTAL CAPTURE
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5229115
• MDR Text Key: 31591884
• Report Number: 0002249697-2015-03774
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

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: AF3L05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249697-10/6/2015-011R
• Patient Sequence Number: 1
• Patient Outcome(s): Other