MAUDE Adverse Event Report: MAKO SURGICAL CORP. X3 TRIATHLON CS INSERT #3 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-313
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	08/21/2019
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.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
In response to follow-up, medical records were provided which indicate the patient had a left knee aspiration on (b)(6) 2019.As noted: ".She has noticed that the area in the back of her knee has 'swelled up again.'.An 18 gauge needle was used to aspirate 90cc of sanguineous fluid from the popliteal space.".
Additional Manufacturer Narrative
Reported event: an event regarding rom and patient factors involving triathlon insert was reported.The event was confirmed via 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 stated that: no examination of explanted component and no immediate post-operative left total knee arthroplasty x-rays or dated serial images prior to an eleven year post-operative x-ray prior to the revision surgery are available.Other than ¿significant wear of the poly insert¿ the event descriptions of the four pi¿s are confirmed by the medical record review.Without serial x-rays and examination of the explanted components it is not possible to determine the possible causation of this late term clinical event, but there is no evidence that factors associated with implant design and materials were responsible for this clinical situation.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 1 other similar events for the reported lot.Conclusion: a review of the provided medical records and/or x-rays by a clinical consultant stated that: no examination of explanted component and no immediate post-operative left total knee arthroplasty x-rays or dated serial images prior to an eleven year post-operative x-ray prior to the revision surgery are available.Other than ¿significant wear of the poly insert¿ the event descriptions of the four pi¿s are confirmed by the medical record review.Without serial x-rays and examination of the explanted components it is not possible to determine the possible causation of this late term clinical event, but there is no evidence that factors associated with implant design and materials were responsible for this clinical situation.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
In response to follow-up, medical records were provided which indicate the patient had a left knee aspiration on (b)(6) 2019.As noted: ".She has noticed that the area in the back of her knee has 'swelled up again.'.An 18 gauge needle was used to aspirate 90cc of sanguineous fluid from the popliteal space.".

• Brand Name: X3 TRIATHLON CS INSERT #3 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10161523
• Report Number: 0002249697-2020-01200
• Device Sequence Number: 3045422
• Product Code: MBH
• UDI-Device Identifier: 07613327045741
• UDI-Public: 07613327045741
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 07/31/2013
• Device Model Number: 5531-G-313
• Device Catalogue Number: 5531G313
• Device Lot Number: LBE055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 74