MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5530-G-513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/02/2018
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: "right knee revision, one component (poly).Mechanical complication of right knee.
Event or Problem Description
It was reported that: "right knee revision, one component (poly).Mechanical complication of right knee.Update (b)(6) 2018 from med review: x-rays shows posterior subluxation of femur and varus instability.
Additional Manufacturer Narrative
An event regarding revision due to joint instability involving a triathlon insert was reported.It was noted on an image provided of the explanted component that a section of the insert fractured.The event was confirmed through the x-rays and photographs provided.Method & results: device evaluation and results: no product was returned for evaluation however one photograph was provided.The photograph shows a recently explanted insert.Damage is visible on one of the two compartments on the posterior edge of the bearing surface.Medical records received and evaluation: a review of the provided medical records were rejected for medical review by a clinical consultant the following comment was provided: x-rays shows posterior subluxation of femur and varus instability; need operative reports, past/clinical medical history.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the damage on the component was confirmed on the photograph of the explanted device and instability was confirmed through review of the x-rays provided however, the exact cause of the event could not be determined because insufficient information was provided.Further information such as product evaluation,operative reports, past/clinical medical history are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8021377
• Report Number: 0002249697-2018-03548
• Device Sequence Number: 1578589
• Product Code: MBH
• UDI-Device Identifier: 07613327050554
• UDI-Public: 07613327050554
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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 Catalogue Number: 5530-G-513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: 71 YR
• Patient Weight: 87