MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL SIZER - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-603

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Triathlon ap sizer moved during drilling to indicate the opposite side.The locking mechanism did not stay engaged in the selected slot which was for the right knee.

Manufacturer Narrative

An event regarding seating/locking issue involving a femoral sizer ¿ standard was reported.The event was confirmed.Method and results: device evaluation and results: during the functional test the lever migrates from one side to the other easily.The trigger spring does move up and down very easily not giving much force.Medical records received and evaluation: not performed as medical records were not provided.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 confirmed that the reported ¿locking mechanism did not stay engaged in the selected slot which was for the right knee.¿ the cause of this was the design of the older version (rev c) of this device did not have the spring length that the updated version (rev f) has.The updated revision has a longer spring length which created more tension to not allow the movement of the lever to move freely.

Event Description

Triathlon ap sizer moved during drilling to indicate the opposite side.The locking mechanism did not stay engaged in the selected slot which was for the right knee.

• Brand Name: FEMORAL SIZER - STANDARD
• 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: 5798141
• MDR Text Key: 50437011
• Report Number: 0002249697-2016-02330
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-603
• Device Lot Number: NMYS02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2009
• 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: 69 YR
• Patient Weight: 79