MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-309
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received image of device noted the retaining wire disassociated from the poly insert.There are no allegations for the wire disassociation.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted, "the event of a revision for failure of a cemented all polyethylene patellar component was confirmed by the operative note.It was not possible to ascribe a root cause to the event.Medical records, serial radiographs and perhaps materials examination of the explant would be required.There was no indication as to the surgeons intraoperative assessment of causes for the patellar component fracture." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient's right knee was revised due to a fractured patellar component.Visual inspection of the received image of device noted the retaining wire disassociated from the poly insert.There are no allegations for the wire disassociation.The available medical records were provided to the consulting clinician for a review which noted that the event of a revision for failure of a cemented all polyethylene patellar component was confirmed by the operative note.It was not possible to ascribe a root cause to the event.Medical records, serial radiographs and perhaps materials examination of the explant would be required.There was no indication as to the surgeons intraoperative assessment of causes for the patellar component fracture.The event of instability was not confirmed nor the exact cause be determined because insufficient information was provided.Additional information including operative reports are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right knee was revised due to a fractured patellar component.Intra-operatively, the pegs of the patellar component were found to have been sheared off.Patient denied any trauma or falls prior to surgery.The pieces of the patellar component were removed and revised, and a 3x9 cr insert was revised by a 3x13 cs insert to increase patient stability.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 11435376
• Report Number: 0002249697-2021-00386
• Device Sequence Number: 14447195
• Product Code: MBH
• UDI-Device Identifier: 07613327050431
• UDI-Public: 07613327050431
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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 Expiration Date: 09/30/2020
• Device Model Number: 5530-G-309
• Device Catalogue Number: 5530-G-309
• Device Lot Number: PL29HL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• 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: 73 YR