MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5542-A-202

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Size 2 15mm distal augment was overhanging on the triathlon femur.Rep reported that augment is not supposed to overhang, and a smaller augment was used off-label.Rep confirmed that no surgical delay was caused.

Manufacturer Narrative

An event regarding a size/fit issue involving a triathlon augment was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided and the device was not returned.Further information such as product evaluation, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Size 2 15mm distal augment was overhanging on the triathlon femur.Rep reported that augment is not supposed to overhang, and a smaller augment was used off-label.Rep confirmed that no surgical delay was caused.

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7285129
• MDR Text Key: 100522697
• Report Number: 0002249697-2018-00511
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327015355
• UDI-Public: 07613327015355
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 5542-A-202
• Device Lot Number: AB34V
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR