MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5531G709

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported that the surgeon revised a size 9 x 3 tibial insert on (b)(6) 2015.Poly was revised due to patient having a grossly loose knee.Surgeon revised poly with a thicker poly.Surgeon revised from a size 9 to size 16 insert.Surgeon noted patient had good range of motion and the explanted poly insert was pristine.

Manufacturer Narrative

An event regarding revision due to instability involving a triathlon cs insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device indicates that the device appears normal for a poly component that was implanted and subsequently explanted.Medical records received and evaluation: not performed as medical records were not received for review.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: based on the visual inspection the returned device indicates that the device appears normal for a poly component that was implanted and subsequently explanted.The surgeon explanted the 9mm thick insert component and replaced it with a 16mm to address the instability in the joint.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the surgeon revised a size 9 x 3 tibial insert on (b)(6) 2015.Poly was revised due to patient having a grossly loose knee.Surgeon revised poly with a thicker poly.Surgeon revised from a size 9 to size 16 insert.Surgeon noted patient had good range of motion and the explanted poly insert was pristine.

• Brand Name: X3 TRIATHLON CS INSERT #7 9MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5062506
• MDR Text Key: 25212760
• Report Number: 0002249697-2015-02938
• 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: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 5531G709
• Device Lot Number: LDH508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• 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