MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5620-B-201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
2019/7/17, initial procedure did.(b)(6) 2019, it was fractured a tibia as plan.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon baseplate was reported.The event was confirmed by medical review.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "x-ray confirms fracture.Need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components." device history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the patient had a fracture of the tibia.The available medical records were provided to a consulting clinician for a review which was rejected stating - x-ray confirms fracture.Need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.The root cause could not be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
On (b)(6) 2019, initial procedure did.On (b)(6) 2019, it was fractured a tibia as plan.

• Brand Name: TRIATHLON PKR BASEPLATE #2 LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9075204
• Report Number: 0002249697-2019-03223
• Device Sequence Number: 2449802
• Product Code: HRY
• UDI-Device Identifier: 07613327015508
• UDI-Public: 07613327015508
• Combination Product (Y/N): N
• PMA/510(K) Number: K082567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 5620-B-201
• Device Lot Number: DGE9HA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: 67 YR