MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5551-G-320

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient took a severe fall on his farm.Patient presented w/ sheared patella.Replaced with 6x13mm x 3 ps insert, lot # p83ry5, catelog # 5532-g-613, asymmetric x3 32 patella, lot # nxd5, catelog # 5551-g-320.

Manufacturer Narrative

An event regarding a crack/fracrure due to trauma involving a triathlon patella was reported.The event was confirmed.Method and results: device evaluation and results: a visual inspection of the returned device noted that the device was returned in used condition.There was a distinct shear damage on the convex side of the patella most probably due to shear stress resulting from the fall.There were many scratches and indentations throughout the device probably due to explantation and normal wear and tear.Material analysis was not performed as the reported event was due to a trauma.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: a visual inspection of the returned device noted that the device was returned in used condition.There was a distinct shear damage on the convex side of the patella most probably due to shear stress resulting from the fall.There were many scratches and indentations throughout the device probably due to explantation and normal wear and tear.Material analysis was not performed as the reported event was due to a trauma.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Patient took a severe fall on his farm.Patient presented w/ sheared patella.Replaced with 6x13mm x 3 ps insert, lot # p83ry5, catelog # 5532-g-613, asymmetric x3 32 patella, lot # nxd5, catelog # 5551-g-320.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6227706
• MDR Text Key: 64016072
• Report Number: 0002249697-2017-00122
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 5551-G-320
• Device Lot Number: VK95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95