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
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of competitor devices, right knee.It was reported the surgeon complained that the augment was overhanging the femoral component on the medial side.The surgeon decided to trim the augment with a diamond wheel (b)(4) so that it didn't overhang the medial anterior femoral flange with a surgical delay of approximately 5 minutes.
Additional Manufacturer Narrative
An event regarding overhang (size/fit issue) involving a triathlon augment was reported.The event was confirmed by image provided.Conclusions: the event was confirmed based on the image provided.The augment was then "trimmed" by the surgeon in an off-label manner.Nc was issued for the overhang of the triathlon augment size 2 10mm and size 2 15mm on the medial side of the size 2 femoral component.The nc determined this to be a design issue and the design will need to corrected.No further investigation for this event is possible at this time.If devices and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision of competitor devices, right knee.It was reported the surgeon complained that the augment was overhanging the femoral component on the medial side.The surgeon decided to trim the augment with a diamond wheel midas so that it didn't overhang the medial anterior femoral flange with a surgical delay of approximately 5 minutes.

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7494385
• Report Number: 0002249697-2018-01361
• Device Sequence Number: 1339200
• Product Code: MBH
• UDI-Device Identifier: 07613327015355
• UDI-Public: 07613327015355
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 5542-A-202
• Device Lot Number: UZIY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR