MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G611

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

Patient Problems Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient had an inadequate range of motion.The doctor resected more distal femur, implanted a thinner tibial insert as well as changed the femur one size smaller.He used a posterior stabilized construction.This was the right side.There was nothing loose or broken.

Manufacturer Narrative

An event regarding poor range of motion involving a triathlon insert component was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: medical review concluded: femoral component malposition with mismatch in flexion-extension gap space causing stiffness and requiring revision with exchange of femoral component and tibial bearing.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 reported events for the lot referenced.Conclusion: clinician review of the medical records provided indicated that femoral component malposition with mismatch in flexion-extension gap space causing stiffness and requiring revision with exchange of femoral component and tibial bearing.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient had an inadequate range of motion.The doctor resected more distal femur, implanted a thinner tibial insert as well as changed the femur one size smaller.He used a posterior stabilized construction.This was the right side.There was nothing loose or broken.

• Brand Name: X3 TRIATHLON CS INSERT #6 11MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5732500
• MDR Text Key: 47625007
• Report Number: 0002249697-2016-01974
• 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: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 5531G611
• Device Lot Number: LEJ415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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
• Patient Age: 63 YR
• Patient Weight: 83