MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-301
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening of the femoral component.Surgeon reported that the distal femur metaphysis looked "disintegrated." patient's knee construct was revised to a hinged distal femur construct.Rep confirmed there are no allegations against the revised tibial baseplate or insert.Rep provided primary and revision usage sheets, pre- and post-revision x-rays, and confirmed that no further information will be released.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening of the femoral component.Surgeon reported that the distal femur metaphysis looked "disintegrated." patient's knee construct was revised to a hinged distal femur construct.Rep confirmed there are no allegations against the revised tibial baseplate or insert.Rep provided primary and revision usage sheets, pre- and post-revision x-rays, and confirmed that no further information will be released.
Additional Manufacturer Narrative
An event regarding loosening involving triathlon femoral component was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: undated x-rays: ap and lat left knee demonstrating uncemented tka with grossly loose femoral component.Undated x-ray: ap left knee demonstrating cemented, modular, long-stem, distal femoral replacement, hinged tka - reduced and nominal position.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no surgical pathology reports, no dated serial x-rays.While the x-rays appear to confirm the event description, insufficient data is present to create a medical report for this case." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that patient's left knee was revised due to loosening of femoral component.The event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including clinical or patient medical history, operative reports, progress notes, dated serial x-rays surgical pathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON CR FEM COMP #3 L-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10475775
• Report Number: 0002249697-2020-01771
• Device Sequence Number: 2605359
• Product Code: MBH
• UDI-Device Identifier: 07613327040258
• UDI-Public: 07613327040258
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 11/30/2024
• Device Model Number: 5510-F-301
• Device Catalogue Number: 5510F301
• Device Lot Number: JLH6D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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
• Patient Age: 58 YR