MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5517F301

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in 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

At the regular follow up visit, something like beads are found on x-rays.The removal is not planned.They were not found on just after surgery x-rays.

Manufacturer Narrative

An event regarding disassociation of beads (porous coating) from the triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the device was not returned, it remains implanted.-medical records received and evaluation: clinician review of the x-rays provided indicate a slight mismatch between actual bone preparation and final implant position has contributed to an overload condition on the beaded implant surface causing abrasion during introduction of the device.-device history review: dhr review was satisfactory.-complaint history review: chr review confirmed that there were no other similar reported events for the lot.Conclusions: based on clinician review of the x-rays provided indicate a slight mismatch between actual bone preparation and final implant position has contributed to an overload condition on the beaded implant surface causing abrasion during introduction of the device.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.

Event Description

At the regular follow up visit, something like beads are found on x-rays.The removal is not planned.They were not found on just after surgery x-rays.

• Brand Name: TRIATHLON P/A CR BEADED #3L
• 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: 5704524
• MDR Text Key: 47995586
• Report Number: 0002249697-2016-01827
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 5517F301
• Device Lot Number: AEN4A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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): Other
• Patient Age: 78 YR
• Patient Weight: 60