MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B500
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional 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 similar events for the reported lot.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.Device remains implanted.
Event or Problem Description
Primary procedure, left knee.Patient was trailed for a size 5 baseplate, which covered the tibial cut.After using the guide to punch the 4 press-fit peg holes, the implant was placed and did not cover the tibial cut though the pegs fit into the holes set by the guide.Surgeon decided that as the implant was stable with no movement, there would be no patient harm by leaving the implant in.Surgery was completed successfully with no delays.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a tritanium baseplate was reported.The event was confirmed through the photograph provided.The reported device was not returned however a photograph was provided for review.The photograph was taken intraoperatively and indicates that the implant has been placed, however it is not covering the tibial cut.It appears well seated on the bone indicating that the pegs fit into the holes set by the guide.The lot number ctd18417 is also evident confirming that this is a size 5 baseplate.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.It is reported that patient was trialed for a size 5 baseplate which covered the tibial cut.After using the guide to punch the 4 press-fit peg holes, the implant was placed and did not cover the tibial cut though the pegs fit into the holes set by the guide.Surgeon decided that as the implant was stable with no movement, there would be no patient harm by leaving the implant in.Surgery was completed successfully with no delays.It is reported that the surgeon felt post op that sizing was ok and that surgical outcome was good.The poor fit is confirmed by the photograph provided, however, the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary procedure, left knee.Patient was trialed for a size 5 baseplate, which covered the tibial cut.After using the guide to punch the 4 press-fit peg holes, the implant was placed and did not cover the tibial cut though the pegs fit into the holes set by the guide.Surgeon decided that as the implant was stable with no movement, there would be no patient harm by leaving the implant in.Surgery was completed successfully with no delays.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• 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: 7848252
• Report Number: 0002249697-2018-02783
• Device Sequence Number: 11156595
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/10/2018

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: 05/31/2023
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD18417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: 67 MO