MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Model Number	5515-F-602
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's right knee was revised due to a surgical error resulting in instability.Rep reported that the gaps were not balanced and that the knee was stable in extension but loose in flexion.Patient was revised to a triathlon ts construct with a larger size 7 femur.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Event or Problem Description
It was reported that patient's right knee was revised due to a surgical error resulting in instability.Rep reported that the gaps were not balanced and that the knee was stable in extension but loose in flexion.Patient was revised to a triathlon ts construct with a larger size 7 femur.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.H3 other text : device not returned.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7704729
• Report Number: 0002249697-2018-02251
• Device Sequence Number: 16805260
• Product Code: MBH
• UDI-Device Identifier: 07613327050424
• UDI-Public: 07613327050424
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5515-F-602
• Device Catalogue Number: 5515-F-602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 11/24/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 96