MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5517-F-702

Device Problem Fitting Problem (2183)

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

Event Date 02/03/2020

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 similar 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

Femur cut with mako, trial seemed to fit well, placed pa beaded femur size 7 right implant on and did not seem to fit properly.Off on anterior chamfer and anterior cut approx 2-3mm.Had to open another implant and.Cement femur.Had to cement femur meant case took approx 15min longer.Case type: tka.

Event Description

Femur cut with mako, trial seemed to fit well, placed pa beaded femur size 7 right implant on and did not seem to fit properly.Off on anterior chamfer and anterior cut approx 2-3mm.Had to open another implant and.Cement femur.Had to cement femur meant case took approx 15min longer.Case type: tka.

Manufacturer Narrative

Reported event: an event regarding seating/locking issues involving a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: examination of the device returned indicated nothing remarkable to report.No evidence of attempted implantation were observed on the implant.Dimensional inspection of the returned device noted the following: the device is dimensionally within specification as per inspection completed by manufacturing cell representative.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #7R
• 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: 9775744
• MDR Text Key: 185496625
• Report Number: 0002249697-2020-00434
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041019
• UDI-Public: 07613327041019
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 5517-F-702
• Device Catalogue Number: 5517F702
• Device Lot Number: E6J6C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 05/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other