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
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
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 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 or Problem 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 or Problem 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.
Additional 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
• 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: 9775744
• Report Number: 0002249697-2020-00434
• Device Sequence Number: 16787605
• Product Code: MBH
• UDI-Device Identifier: 07613327041019
• UDI-Public: 07613327041019
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 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
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 05/24/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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