MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-602
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product 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, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Event: doctor was implanting size 6 right cr beaded femur with pa.Noticed implant was not seating as expected.Opened size 6 right cemented femur and cemented the femur on.There were no visual imperfections to the removed beaded femur.The removed femur is not available for return secondary to hospital protocol.There were no adverse complications to the patient with the cemented femur.No issues with other implants.The surgeon nor the patient request results of report.

• Brand Name: TRIATHLON P/A CR BEADED #6R
• 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: 11056611
• Report Number: 0002249697-2020-02751
• Device Sequence Number: 11433926
• Product Code: MBH
• UDI-Device Identifier: 07613327040999
• UDI-Public: 07613327040999
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 06/30/2025
• Device Model Number: 5517-F-602
• Device Catalogue Number: 5517F602
• Device Lot Number: LAH6E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/22/2020
• 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
• Patient Age: 62 YR