MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM16X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6478-6-715
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	10/25/2019
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Patient with mrh in situ.Patient has stability problems.During surgery they discover a loose femur component.When component has been removed they discover that the stem under the femur component has been broken.It took a lot of effort to take out the broken stem.During this extraction the femur broke.Patient now needs another surgery for a gmrs.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a duracon stem was reported.The event was confirmed based on evaluation of the returned device.Method & results: product evaluation and results: the stem fractured in fatigue at the threaded portion, indicated by the observed striations.Bone cement was observed on the femoral component that extended beyond the condyles.Burnishing, scratching, and third body indentation were observed on the tibial insert; these are common damage modes of uhmwpe.Damage consistent with the contact against a hard object process was observed on the bumper, tibial insert, and femoral component.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined for the tibial insert, bumper, stem, and tibial rotating components.The catalog number was not provided for the femoral component; consistency with the drawing could not be established.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: evaluation of the returned devices indicated that the stem fractured in fatigue at the threaded portion, indicated by the observed striations.Bone cement was observed on the femoral component that extended beyond the condyles.Burnishing, scratching, and third body indentation were observed on the tibial insert; these are common damage modes of uhmwpe.Damage consistent with the contact against a hard object process was observed on the bumper, tibial insert, and femoral component.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined for the tibial insert, bumper, stem, and tibial rotating components.The catalog number was not provided for the femoral component; consistency with the drawing could not be established.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient with mrh in situ.Patient has stability problems.During surgery they discover a loose femur component.When component has been removed they discover that the stem under the femur component has been broken.It took a lot of effort to take out the broken stem.During this extraction the femur broke.Patient now needs another surgery for a gmrs.

• Brand Name: TI DUR REG FLUTED STEM16X155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9385714
• Report Number: 0002249697-2019-03912
• Device Sequence Number: 479997
• Product Code: JWH
• UDI-Device Identifier: 07613327045031
• UDI-Public: 07613327045031
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/17/2020

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 Expiration Date: 03/31/2018
• Device Model Number: 6478-6-715
• Device Catalogue Number: 64786715
• Device Lot Number: T3227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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