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

Model Number	5530-G-609
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient's left knee was revised.As reported: "pain and instability.All available information submitted." a 6x9 cr insert was revised to a 6x13 cs insert.Rep provided x-rays, primary operative report, and explant picture.
Event or Problem Description
Patient's left knee was revised.As reported: "pain and instability.All available information submitted." a 6x9 cr insert was revised to a 6x13 cs insert.Rep provided x-rays, primary operative report, and explant picture.
Additional Manufacturer Narrative
An event regarding instability & crack/fracture involving a triathlon insert was reported.The event was confirmed by review of the case by a medical consultant.Method & results: device evaluation and results: visual inspection: as per the medical review comments, having reviewed the provided photograph of the explanted insert: 'provided poly image shows posterior portion fracture' material analysis,functional and dimensional inspections could not be performed as the device was not returned.  clinician review:  a review of the provided medical records by a clinical consultant stated the following comment: 'provided x-ray confirms instability.Provided poly image shows posterior portion fracture, need revision report to confirm if poly fracture was due to trauma from explantation, need additional information; revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components.' 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.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9437536
• Report Number: 0002249697-2019-03977
• Device Sequence Number: 2499691
• Product Code: MBH
• UDI-Device Identifier: 07613327050585
• UDI-Public: 07613327050585
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 5530-G-609
• Device Catalogue Number: 5530-G-609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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: 61 YR
• Patient Weight: 137