MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5536B500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding a knee revision was reported.Periprosthetic fracture involving a titanium baseplate was confirmed through medical records.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated that some 2-weeks post primary surgery the patient returned with pain and on x-ray a periprosthetic fracture evident below the baseplate with severe dislocation.Revision surgery was performed on (b)(6) 2017, no details provided, no info on further outcome.He further states it is quite likely that an unknown patient trauma (because not reported or due to lack of information), has been a principal factor to contribute to the problem and caused the pp-fracture.This represents an overload condition by external traumatic forces which is a typically patient-related event that is beyond control of anyone.Device history review: the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review indicated that possibly an unreported ¿stumble¿ or fall early post arthroplasty has contributed to a periprosthetic fracture requiring revision surgery within 2-weeks of initial arthroplasty.The exact cause of the event could not be determined because insufficient information was provided.Further information such as revision surgery operative notes and additional follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received, if devices or additional information become available, this investigation will be reopened.
Event or Problem Description
Sales rep reported patient had knee revision.Update per medical review: the patients' revision was due to a periprosthetic fracture.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• 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: 6969917
• Report Number: 0002249697-2017-03085
• Device Sequence Number: 10780370
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

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: 12/14/2021
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD13537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/23/2017
• 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: Other; Required Intervention
• Patient Age: 65 YR