MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5541-A-402
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 [(b)(6) 2016 revision was of competitor devices].The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information is available.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon augment was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which was deemed insufficient stating - "need operative reports, office/clinical reports, serial x-rays, etc".Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been one other events for the lot referenced which is related to the same the surgery.Conclusion: it was reported that revision surgery took place due to loosening of the femoral components.The available medical records were provided to the consulting clinician who deemed it insufficient for a medical review.The event could not be confirmed with the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays 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.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 ((b)(6) 2016 revision was of competitor devices).The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information is available.

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 4 RIGHT
• 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: 8520623
• Report Number: 0002249697-2019-01636
• Device Sequence Number: 19200926
• Product Code: MBH
• UDI-Device Identifier: 07613327015232
• UDI-Public: 07613327015232
• 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: 2016
• 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): 06/04/2019

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: 05/31/2021
• Device Catalogue Number: 5541-A-402
• Device Lot Number: U4VY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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: 49 YR