MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5510F501
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the sterile 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
Revised total knee for infection and loose components.Tibia and femur were loose.Infection reported by surgeon, unknown if clinically confirmed or identified.Further information will not be provided by the surgeon or hospital.
Additional Manufacturer Narrative
An event regarding loosening and infection involving a triathlon femoral component was reported.Loosening was confirmed on review of the provided x-rays by a clinical consultant.Infection was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review of the provided x-ray by a clinical was rejected due to insufficient being provided.The review did confirm the loosening but not to root cause of this loosening.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: loosening was confirmed on review of the provided x-ray however the root cause could not be determined.Infection was not confirmed.Additional information needed such as primary and revision operative reports, serial x-rays and examination of explanted components are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Revised total knee for infection and loose components.Tibia and femur were loose.Infection reported by surgeon, unknown if clinically confirmed or identified.Further information will not be provided by the surgeon or hospital.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• 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: 7801483
• Report Number: 0002249697-2018-02620
• Device Sequence Number: 18889299
• Product Code: MBH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/11/2018

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: 06/30/2015
• Device Catalogue Number: 5510F501
• Device Lot Number: STNTC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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: 68 YR
• Patient Weight: 98